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A Randomized Trial of Home Oxygen Therapy From the Emergency
                   Department for Acute Bronchiolitis
               Lalit Bajaj, Carol G. Turner and Joan Bothner
                       Pediatrics 2006;117;633-640
                       DOI: 10.1542/peds.2005-1322


The online version of this article, along with updated information and services, is
                       located on the World Wide Web at:
              http://www.pediatrics.org/cgi/content/full/117/3/633




PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
Grove Village, Illinois, 60007. Copyright © 2006 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.




   Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
ARTICLE




A Randomized Trial of Home Oxygen Therapy From
the Emergency Department for Acute Bronchiolitis
Lalit Bajaj, MD, MPHa, Carol G. Turner, MDb, Joan Bothner, MDa

aDepartment of Pediatrics, Section of Emergency Medicine, University of Colorado Health Sciences Center/Children’s Hospital, Denver, Colorado; bAspen Park Pediatrics,

Conifer, Colorado

The authors have indicated they have no financial relationships relevant to this article to disclose.




ABSTRACT
OBJECTIVE. Hypoxia is a common reason for hospital admission in infants and chil-
dren with acute bronchiolitis. No study has evaluated discharge from the emer-
                                                                                                                              www.pediatrics.org/cgi/doi/10.1542/
gency department (ED) on home oxygen. This study evaluated the feasibility and                                                peds.2005-1322
safety of ED discharge on home oxygen in the treatment of acute bronchiolitis.                                                doi:10.1542/peds.2005-1322
METHODS. This was a prospective, randomized trial of infants and children with acute                                          Key Words
                                                                                                                              bronchiolitis, hypoxia, oxygen, home
bronchiolitis and hypoxia (room-air saturations of Յ87%) aged 2 to 24 months                                                  therapy, observation
presenting to an urban, academic, tertiary care children’s hospital ED from De-                                               Abbreviations
cember 1998 to April 2001. Subjects received inpatient admission or home oxygen                                               PCP—primary care provider
after an 8-hour observation period in the ED. We measured the failure to meet                                                 ED— emergency department
                                                                                                                              RDSS—respiratory distress severity score
discharge criteria during the observation period, return for hospital admission, and
                                                                                                                              Accepted for publication Jul 22, 2005
incidence of serious complications.                                                                                           Address correspondence to Lalit Bajaj, MD,
                                                                                                                              MPH, Department of Pediatrics/Section of
RESULTS. Ninety-two patients were enrolled. Fifty three (58%) were randomly as-                                               Emergency Medicine, University of Colorado
signed to home and 39 (42%) to inpatient admission. There were no differences                                                 Health Sciences Center/Children’s Hospital,
                                                                                                                              1056 E 19th Ave B251, Denver, CO 80218. E-
between the groups in age, initial room-air saturation, and respiratory distress                                              mail: bajaj.lalit@tchden.org
severity score. Of 53 patients, 37 (70%) randomly assigned to home oxygen                                                     PEDIATRICS (ISSN Numbers: Print, 0031-4005;
completed the observation period and were discharged from the hospital. The                                                   Online, 1098-4275). Copyright © 2006 by the
                                                                                                                              American Academy of Pediatrics
remaining 16 patients were excluded from the study (6), resolved their oxygen
requirement (5), or failed to meet the discharge criteria and were admitted (5).
One discharged patient (2.7%) returned to the hospital and was admitted for a
cyanotic spell at home after the 24-hour follow-up appointment. The patient had
an uncomplicated hospital course with a length of stay of 45 hours. The remaining
36 patients (97%) were treated successfully as outpatients with home oxygen.
Satisfaction with home oxygen was high from the caregiver and the primary care
provider.
CONCLUSIONS. Discharge from the ED on home oxygen after a period of observation
is an option for patients with acute bronchiolitis. Secondary to the low incidence
of complications, the safety of this practice will require a larger study.




                                                                                                              PEDIATRICS Volume 117, Number 3, March 2006                   633
                         Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
B      RONCHIOLITIS IS THE most common cause of hospital
       admission in children Ͻ1 year of age. An estimated
80 000 to 120 000 children Ͻ1 year of age are admitted
                                                                 fined as (1) not requiring transfer to the intensive care
                                                                 unit (ICU), (2) not being readmitted to the hospital after
                                                                 discharge, and (3) not having any serious complications.
annually. Hospitalization rates have been increasing dra-        Serious complications were defined as respiratory arrest,
matically, with estimates of an increase of 239% in              apnea, cyanotic spell, and respiratory failure. The success
children Ͻ6 months from 1980 to 1996.1 One of the                rate for hospitalized patients was estimated at 99%. Us-
hypotheses for this dramatic increase is the almost uni-         ing a minimum success rate of 90% for home oxygen,
versal use of pulse-oximetry screening and the imple-            we estimated that ϳ160 patients (80 in each group)
mentation of an oxygen-saturation cut off that warrants          would be needed with an ␣ value of .05 and a ␤ value of
hospital admission for supplemental oxygen. The need             .20.
for supplemental oxygen therapy in a previously healthy             Patients were enrolled over 3 consecutive winter sea-
patient is considered by many to require mandatory               sons from December 1998 to April 2001 at an urban,
admission and is included as one of the therapies defin-          academic, tertiary care children’s hospital at an elevation
ing mandatory admission in studies evaluating a pediat-          of 5280 ft (1609 m). All of the patients received deep
ric risk of admission score.2,3 It has also been demon-          nasal suctioning and 2 albuterol treatments (2.5 mg) via
strated that physicians use the oxygen-saturation                nebulizer over the first 60 minutes. All of the patients
information frequently to determine whether a patient            had their respiratory distress severity score (RDSS) (Ta-
requires hospital admission.4 A recent study addressed           ble 1) documented at the start of the study, after suc-
how often patients remain in the hospital only for sup-          tioning, and after the nebulizer treatments. The RDSS
plemental oxygen after other clinical parameters (oral           has 4 categories: respiratory rate, wheezing, aeration,
intake and work of breathing) have improved and found            and retractions, and each category has a scoring system
that 26% of patients have a prolonged stay of an average         of 0, 1, or 2 points. The total score is obtained by adding
of 1.6 days.5                                                    the score from each category. All of the patients then
   In the years preceding this study, community primary          received a chest radiograph, and, if read by the attending
care providers (PCPs) were faced with a rapidly expand-          radiologist as consistent with an acute bacterial pneu-
ing population of children and a large burden of patients        monia, the patient was not approached for enrollment in
with bronchiolitis requiring oxygen. Hospital beds               the study.
around the community were becoming very difficult to                 Caregivers were approached during times at which a
find, and the practice of arranging home oxygen from              research assistant was available to assess whether they
the office setting began to emerge. This was especially           met the inclusion criteria or had any of the exclusion
true in practices that had close relationships with their        criteria (Table 2). Informed consent was obtained, and
patients and felt comfortable that if any deterioration          patients were randomly assigned to traditional inpatient
occurred, the caregivers would quickly notify them and           hospitalization or to home oxygen therapy. Randomiza-
present to a local emergency department (ED). To date,           tion was performed by using a block-randomization ta-
there are no publications evaluating the use of home             ble created before the start of the study. Research assis-
oxygen therapy from the ED or the primary care clinic in         tants were blinded to allocation at the time of
patients with acute bronchiolitis requiring supplemental         enrollment. The study packet with the assignment could
oxygen. We undertook a prospective, randomized pilot             not be opened until informed consent had been ob-
study of home oxygen from the ED compared with                   tained. Patients randomly assigned to the inpatient arm
traditional inpatient hospitalization to assess for the fea-     of the study had an RDSS recorded every 2 hours for the
sibility and safety of this practice.                            first 8 hours of hospitalization. Other treatments in the
                                                                 hospital were at the discretion of the inpatient attending,
METHODS                                                          and the families were contacted at 1 week by telephone
We conducted a prospective, randomized trial of tradi-           and were asked to answer questions from a standardized
tional inpatient hospitalization versus home oxygen              questionnaire. A chart review was also performed to
from the ED in a convenience sample of patients with             extract hospital complications and length of stay data.
acute bronchiolitis and hypoxia. In preparation for con-            Patients randomly assigned to the home oxygen arm
ducting the study, we sent out information letters to all
PCPs who refer patients to our ED to let them know
what the study would require of them if a patient in              TABLE 1 RDSS
their practice was enrolled.                                     Score          Respiratory Rate               Wheezing     Aeration    Retractions
   A sample-size calculation was performed before the                          0–1 y           1–2 y
start of the study. The success of the home oxygen                 0           20–40           15–30         None           All fields     None
protocol was defined as (1) not requiring hospitalization           1           41–55           31–45         Mild-Exp       Ն4 fields      Mild
after ED discharge and (2) not having any serious com-             2            Ͼ55             Ͼ45          Insp and Exp   Ͻ4 fields      Marked
plications. Success with hospitalized patients was de-           Total score: 0 – 4, mild; 5–7, moderate; Ͼ8, severe.



634   BAJAJ, et al
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TABLE 2 Inclusion/Exclusion Criteria
Inclusion criteria
   2–24 mo, minimum of 44 wk after conceptional age
   Clinical diagnosis of bronchiolitis defined as an acute respiratory illness
      associated with nasal congestion, cough, diffuse wheezing or crackles, and
      tachypnea or retractions
   Chest radiograph consistent with viral bronchiolitis
   First episode of wheezing
   Room-air saturation of Յ87% on arrival to the ED
   Family has transportation to return to PCP or ED 24 and 48 h after discharge
      from the ED
   Lives at altitude Յ6000 ft (1829 m)
   Lives Յ30 min from an emergency medical facility
   Caregivers must maintain a smoke-free environment defined as no smoking in
      house or car
   Caregivers must have a contact telephone number
Exclusion criteria
   Preexisting cardiac, pulmonary (including bronchopulmonary dysplasia),
      neuromuscular, or nutritional (including failure to thrive) disorders and
      preexisting congenital or acquired airway anomalies
   Ͻ44 wk after conceptional age
   History of apnea
   Acute bacterial pneumonia as defined as a focal infiltrate on chest radiograph
   Prior episode of wheezing
   Room-air saturations Ͼ87%
   No available transportation for follow-up visits
   Lives at altitude Ͼ6000 ft (1829 m)
   Lives Ͼ30 min from health care facility
   Steroid administration
   Caregivers unable to stay with patient in observation unit




of the study were placed in the ED observation unit for
an 8-hour observation period. Standard observation
consisted of continuous pulse oximetry and vital-sign
checks every 2 hours. An RDDS was assigned every 2
hours. Four separate pulse-oximetry measurements
were recorded while on oxygen (asleep and feeding
were mandatory). At the end of the observation period,
the following defined discharge criteria had to be met:
saturations of Ն90% on Յ1 L/min nasal cannula oxygen
while the patient was awake, asleep, and feeding; the
                                                                                   FIGURE 1
patient must be able to maintain hydration; the patient                            Treatment protocol.
must have no signs of deteriorating respiratory status;
the attending physician and caregiver must be comfort-
able with discharge; and 24-hour follow-up must be                                 incidence of serious complications. Secondary outcome
arranged. Patients were taught the operation of the por-                           measures were caregiver satisfaction, caregiver prefer-
table home oxygen unit and were given the unit before                              ence, PCP satisfaction, and PCP preference.
discharge. Patients were discharged on Յ1 L nasal can-                                Data were analyzed by using SPSS 12.0 (SPSS Inc,
nula oxygen.                                                                       Chicago, IL). Differences between groups were analyzed
   Standardized questionnaires were completed by the                               by the Student’s t test for continuous variables and the
PCP at the 24- and 48-hour visit and were faxed back to                            ␹2 test for categorical variables. This study was approved
the study coordinator. At 72 hours, a telephone fol-                               by the Colorado Multiple Institutional Review Board
low-up questionnaire was administered to both the PCP                              and the Kaiser Permanente Institutional Review Board.
and the caregiver. A 1-week telephone follow-up ques-
tionnaire was also administered to the caregiver. Fig 1                            RESULTS
displays the treatment protocol.                                                   Ninety-two patients were enrolled over 3 consecutive
   Primary outcome measures included failure to meet                               bronchiolitis seasons. A modified consolidated standards
discharge criteria during the observation period, return                           of reporting trials diagram is presented in Fig 2. These
for hospital admission after successful discharge, and                             patients had a mean age of 7.8 months, a mean room-air


                                                                                                         PEDIATRICS Volume 117, Number 3, March 2006   635
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TABLE 3 Demographics/Clinical Characteristics of Randomized
                                                                              Patients (n ‫)29 ؍‬
                                                                              Characteristic         Overall     Home       Inpatient    P
                                                                                                    (n ϭ 92)    (n ϭ53)      (n ϭ 39)
                                                                     Age, mo
                                                                        Mean                          7.8        7.6          8.2       .606a
                                                                        Range                         2–23       2–21.4      2.1–23
                                                                     Gender, n (%)
                                                                        Male                         52 (57)     29 (55)     23 (59)    .424b
                                                                        Female                       40 (43)     24 (45)     16 (41)
                                                                     Maternal age, y
                                                                        Mean                         27.06       26.68       27.59      .541a
                                                                        Range                        16–43      18–43        16–43
                                                                     Initial RDSS
                                                                        Mean                          4.23        4.13        4.43      .366a
                                                                     Initial room-air saturation,    85.0        84.3        85.8       .208a
                                                                            mean, %
                                                                     8-h RDSS, mean                   2.28        2.31        2.25      .876a
                                                                     8-h O2 required, L/min
                                                                        Mean                          0.485       0.436       0.560     .037a
                                                                        Range                       0.125–1     0.125–1     0.125–1
                                                                     a Student’s    t test.
                                                                     b ␹2   test.



                                                                      TABLE 4 Demographics/Clinical Characteristics of Patients
FIGURE 2                                                                      Completing Study (n ‫)07 ؍‬
Modified consolidated standards of reporting trials diagram.
                                                                              Characteristic         Overall     Home       Inpatient    P
                                                                                                    (n ϭ70)     (n ϭ 37)     (n ϭ 33)
                                                                     Age, mo
saturation of 85%, a mean RDSS of 4.23, and a mean                      Mean                         7.54        7.09         8.02      .438a
                                                                        Range                       2–22.4      2–17.4       2–22.4
oxygen requirement of 0.485 L/min.
                                                                     Gender, n (%)
    Fifty-three patients (58%) were randomly assigned to                Male                        39 (55.7)   19 (51.4)   20 (60.6)   .478b
home, and 39 (42%) were randomly assigned to inpa-                      Female                      31 (44.3)   18 (48.6)   13 (39.4)
tient admission. There were no differences between the               Initial RDSS, mean               4.04        3.72        4.39      .069a
groups in age, initial room-air saturation, and initial              Initial room-air saturation,    85.1        84.8        85.4       .659a
                                                                            mean, %
RDSS. There was a statistically significant difference in
                                                                     8-h RDSS, mean                   2.04        1.86        2.25      .262a
the amount of oxygen required at 8 hours for the pa-                 8-h O2 required, L/min
tients who had been admitted versus those who were                      Mean                          0.492       0.434       0.563     .013a
discharged (Table 3). These relationships remained the                  Range                       0.125–1     0.125–1     0.125–1
same when patients completing the study were analyzed                a Student’s    t test.
                                                                     b ␹2   test.
(Table 4). Based on the actual number of patients en-
rolled and a success rate of 99% in the hospitalized
patients, we would detect an 80% success rate in the
home oxygen patients as a statistically significant differ-           tion period and were discharged with no supplemental
ence.                                                                oxygen. These 5 patients did not return to the study
    Of the 53 patients, 37 (70%) randomly assigned to                institution in the following week for any additional care.
home oxygen completed the observation period and                     The remaining 5 patients did not meet discharge criteria
were discharged from the hospital. Six patients (11.3%)              and were subsequently admitted to the hospital for fur-
failed to complete the observation period: 2 patients                ther care: 2 patients had concerns from the nursing staff
were diagnosed with pneumonia from their chest radio-                and attending physician for inadequate oral intake, 2
graph that was obtained after enrollment instead of be-              patients had concerns for increased work of breathing,
fore randomization, 3 withdrew secondary to caregiver                and 1 patient was given a change in diagnosis to reactive
anxiety, and 1 was excluded secondary to transfer from               airways disease and was given oral corticosteroids. Thir-
another facility, which did not allow for the ascertain-             ty-seven patients were successfully sent home with
ment of initial data.                                                home oxygen.
    Ten patients completed the observation period but                   One patient (2.7%; 95% confidence interval: 0.6 –
were unable to complete the remainder of the study: 5                13.8%) of the 37 discharged from the ED returned to the
resolved their oxygen requirement during the observa-                hospital and was admitted for a cyanotic spell at home


636      BAJAJ, et al
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after the 24-hour follow-up appointment. This was a                   1 patient resolved the oxygen requirement before reach-
4-month-old who was sent to the ED from the 24-hour                   ing the inpatient bed, 1 family became uncomfortable
follow-up visit with a history of a possible cyanotic spell           with being in a research study, and 2 patients had in-
at home. The patient had an uncomplicated hospital                    complete medical charts for review. The patient dis-
course with a length of stay of 45 hours. This is the only            charged who no longer required supplemental oxygen
patient who had a serious complication in the study. The              did not return in the following week for additional care
remaining 36 patients (97%; 95% confidence interval:                   to the study institution. The remaining 33 patients were
86 –99%) were treated successfully as outpatients with                available for analysis.
home oxygen therapy.                                                     The hospitalized patients had a mean length of stay of
    Of the 37 patients, 33 (89%) had a 24- or 48-hour                 1.8 days, with a range of 0.58 to 6.3 days. Five of the
survey completed by their PCP; 33 (89%) had a com-                    patients (15.2%) had a hospital stay of Ͼ3 days (Table
pleted 72-hour telephone follow-up; and 35 (95%) had                  6). Of these 5 patients, 2 were diagnosed with pneumo-
a completed 1-week telephone follow-up. All 37 (100%)                 nia on subsequent chest radiograph, and 1 was diag-
of the patients had at least 1 of the 3 follow-up surveys             nosed with pneumonia and required intravenous fluids.
completed (Table 5).                                                  One patient was a former 29-week infant who had no
    At the 24/48-hour follow-up, 97% of the caregivers                complications noted, and the remaining patient had no
were satisfied with their child at home, and 94% of the                complications noted. Twenty six of the patients (79%)
PCPs were satisfied with the patient being at home. At                 were discharged from the inpatient medical service on
the 72-hour telephone follow-up we asked about pref-                  home oxygen. There were no patients who required
erence, and 79% of the caregivers stated that they pre-               transfer to the ICU, and there were no readmissions
ferred to be at home, and 15% of the caregivers would                 within 1 week after discharge. All 33 of the patient’s
have preferred to be in the hospital. Sixty-four percent              caregivers were successfully contacted at the 1-week
of the PCPs stated they preferred their patients to be at             telephone follow-up; 36% of the caregivers would have
home, whereas 27% of them would have preferred the                    preferred home care, 49% preferred hospital care, and
hospital. At the 72-hour survey, 100% of the caretakers               15% had no opinion (Table 7).
felt they had received adequate instruction on the use of                Analysis of self-reported data on missed days from
home oxygen. Ninety-seven percent (34 of 35) of the                   work showed a trend in less missed days from work in
patients at the 7-day follow-up were satisfied with home               the home oxygen group versus the hospitalized group
oxygen for their child. Four patients (11%) were still on             (mean: 1.72 vs 2.69, respectively). This finding was not
oxygen at a week follow-up (Table 5).                                 statistically significant.
    Thirty-nine patients (42%) were randomly assigned
to traditional inpatient hospitalization. Six patients were           DISCUSSION
excluded from the study: 2 patients were diagnosed with               This study describes the discharge on home oxygen from
pneumonia from their chest radiograph that was ob-                    the ED after an 8-hour period of observation of infants
tained after enrollment instead of before randomization,              with uncomplicated bronchiolitis. This practice is be-



                 TABLE 5 Caregiver/PCP Satisfaction With Home O2 (n ‫)73 ؍‬
                        Variable                    24/48-h Visit              72-h Telephone            7-d Telephone
                                                  Questionnaire at              Questionnaire            Questionnaire
                                              PCP Office (33 of 37), n (%)      (33 of 37), n (%)        (35 of 37), n (%)
                Caregiver satisfied at home            32/33 (97)                  31/33 (94)               34/35 (97)
                Caregiver preference
                   Home                                                            26 (79)
                   Hospital                                                         5 (15)
                   No preference                                                    2 (6)
                PCP preference
                   Home                                                            21 (64)
                   Hospital                                                         9 (27)
                   No preference                                                    3 (9)
                PCP satisfaction                      31/33 (94)
                Adequate instruction                                             33/33 (100)
                Parent observation length
                   Too short                                                        1 (3)
                   Right                                                           13 (40)
                   Too long                                                        15 (45)
                   No opinion                                                       4 (12)
                Still on O2 at 1 wk                                                                        4/35 (11.4)



                                                                                        PEDIATRICS Volume 117, Number 3, March 2006   637
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TABLE 6 Hospitalized Patients (n ‫)33 ؍‬                                                 with supplemental oxygen for bronchiolitis. Other au-
                        Variable                             Hospitalized Patients      thors have indicated that the management of bronchi-
                                                                   (n ϭ 33)             olitis varies widely in both the ED setting, as well as the
Length of stay, d                                                                       inpatient setting, and is not based on clear evidence of
   Mean                                                              1.83               efficacy of treatment options.12–14
   Range                                                          0.58–6.33                 The implementation of clinical care pathways have
Ͼ3 d of hospitalization, n/N (%)                                  5/33 (15.2)
                                                                                        been shown to decrease ancillary testing and overall cost
Discharged on home O2, n/N (%)                                   26/33 (79)
Telephone questionnaire at 7 d, n/N (%)                          33/33 (100)            and length of stay; however, use of home oxygen after
Caregiver preference                                                                    ED evaluation and observation have not been part of
   Home, n (%)                                                       12 (36)            published guidelines to date.15–18 Hospitalization rates for
   Hospital, n (%)                                                   16 (49)            bronchiolitis have increased 239% over the past 2 de-
   No opinion, n (%)                                                  5 (15)
                                                                                        cades for children Ͻ6 months of age.1 During that time
                                                                                        period, mortality rates remained relatively constant.19
                                                                                        This increase in admission frequency has been postu-
 TABLE 7 Days Missed From Work: Home Versus Hospital                                    lated to relate to perhaps an increased reliance on pulse-
 Days                               Home          Hospital                       P      oximetry measurements.4 In a retrospective analysis of
Missed                             (n ϭ 37)       (n ϭ 33)
                                                                                        62 patients admitted for bronchiolitis, Schroeder et al5
Mean                                 1.72           2.69                        .145a   showed that hospitalization was prolonged by an aver-
a Student’s   t test.
                                                                                        age of 1.6 days in 16 patients (26%) because of oxygen-
                                                                                        ation concerns based on pulse-oximetry readings after
                                                                                        all of the other discharge criteria were met. These pro-
coming more common in many sectors of the medical                                       longed hospitalizations are not without potential addi-
community and in PCP offices without benefit of mea-                                      tional costs and the risk of adverse events.20
surement of return rates, subsequent ED visit for wors-                                     To enroll patients with uncomplicated cases of bron-
ening disease, or hospital admission. The reasons for this                              chiolitis, we chose to obtain a chest radiograph on all of
change in clinical practice are not known but could                                     the patients to exclude possible bacterial pneumonia,
reflect a perceived overcrowding of EDs, the belief that                                 foreign bodies, pulmonary edema, and other cardiac or
bronchiolitis is a mild disease in most infants, that the                               respiratory tract abnormalities. Standard care at the time
need for oxygen is often the only reason for hospital                                   of our study included deep nasal suction and a trial of
admission, ease of care of patients on home oxygen, and                                 beta agonists. We realize that these aspects of bronchi-
the fact that home oxygen has become easily accessible                                  olitis care, with the exception of nasal suctioning, may
from home health care companies in recent years.                                        no longer be necessary. We used a respiratory distress
   The use of home oxygen therapy and subsequent                                        score modeled from a previously published respiratory
early nursery discharge has been evaluated in the man-                                  distress score to have an objective measure of respiratory
agement of premature infants with bronchopulmonary                                      distress to allow for comparison between the 2 groups at
dysplasia and chronic lung disease and has been shown                                   enrollment and discharge home.21 However, we did not
to be safe and effective, with an associated decrease in                                incorporate this score as either inclusion or exclusion
cost and no increase in morbidity or readmission rates.6,7                              criteria or as discharge criteria. The study investigator
Families, when surveyed, responded 94% of the time                                      team felt that incorporating an absolute cut-off score for
that they would again take an infant home on oxygen,                                    discharge home would be difficult and that the clinical
and this practice is now routine.8,9 This approach has not                              measures listed in the discharge criteria would be more
yet become the standard of care for older infants and                                   clinically relevant.
children with acute respiratory tract illness. In 2001,                                     Our methodology also included a mandatory 8-hour
Wilson et al10 evaluated care for patients Ͻ1 year of age                               observation period to allow for varying stages of disease
admitted with bronchiolitis in 10 children’s medical cen-                               at the time of enrollment. This observation period
ters and found that care varied widely, that variations                                 proved to be of significant benefit and affected care in 10
could not be explained by difference in disease severity,                               (21%) of 47 patients. Five patients were found to no
and that there was no evidence that a greater intensity of                              longer require supplemental oxygen and were dis-
care affected morbidity or mortality. The use of home                                   charged from the hospital. These patients were an un-
oxygen was not measured. In a letter to the editor of                                   expected finding. We removed the patients from the
Pediatrics concerning this publication, Weiss and Anna-                                 study at that time, because it did not seem reasonable to
malai11 queried the issue of standardized discharge cri-                                require these families to adhere to the stringent fol-
teria from the hospital for patients with bronchiolitis.                                low-up requirements. They did receive standard bron-
They report on a survey of chief residents at 30 chil-                                  chiolitis discharge instructions to return immediately for
dren’s hospitals, and, of the 17 responses, only 2 hospi-                               any concern of increased work of breathing, cyanosis,
tals reported that they routinely send patients home                                    poor feeding, or any other concerns. Because these pa-


638           BAJAJ, et al
                            Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
tients were observed for an extended period of time and          Bronchiolitis is the most common cause of lower
were found to be hypoxic at the start of their evaluation,    respiratory disease that requires hospital admission and
we performed chart review on these patients, and none         contributes significantly to health care costs.22 Home
of them returned to the study institution in the follow-      management may decrease these costs, as has been dem-
ing week for additional care. The remaining 5 patients        onstrated with infants discharged on home oxygen from
were subsequently admitted to the hospital. None of           the newborn nursery. Although it did not reach signifi-
these patients were transferred to the ICU. Only 1 pa-        cance, we also demonstrated a trend toward less missed
tient was readmitted for a questionable cyanotic episode      days of work for families who were randomly assigned to
at home and experienced no additional episodes during         home therapy. Family economic impact, ability to com-
the subsequent 45-hour inpatient admission.                   ply with prescribed care plans, and overall acceptance of
    Our sample size is too small to evaluate the ideal        home oxygen therapy for acute respiratory disease in
period of observation, although the 8-hour time period        infants and children has not been fully evaluated and
we chose allowed some patients to improve and identi-         warrants further study.
fied some patients that failed. Our results do support the        Our study has several limitations. This is a conve-
use of an observation period rather than immediate            nience sample of patients who presented with bronchi-
discharge after evaluation and diagnosis.                     olitis, and we have no information on patients who were
    Our study showed high rates of caregiver and PCP          not enrolled; in addition, there is the potential of selec-
satisfaction with both inpatient admission and discharge      tion bias. Patients who required higher levels of oxygen,
after observation in the ED on home oxygen therapy.           presented with more respiratory distress, or did not at
Only 15% of the caregivers of the patients discharged         first impression seem to have a good home environment
from the ED on oxygen therapy at the time of the              may have been excluded. Our patient population is also
72-hour follow-up questionnaire stated that they would        a referred population, so it may not be reflective of
have preferred hospital admission, whereas 36% of care-       patients who present to other sites of care such as a
givers of the hospitalized patients would have preferred      primary care clinic or office. Caregivers and ED physi-
to have been treated at home. Forty-nine percent of the       cians were not blinded to which treatment arm the
caregivers of the hospitalized patients preferred hospital    patient was assigned, which may have affected treat-
admission. The preference for home treatment was              ment decisions. Our strict inclusion and exclusion crite-
higher among caregivers than among PCPs. PCPs of the          ria, as well as the performance of the study at an altitude
patients discharged from the ED would have preferred          of 5280 ft (1609 m), limit the external validity of the
hospital admission 27% of the time. The reason for this       results.
is unclear. We feel that the comfort level and preference        The study was stopped before the enrollment of the
for discharge on oxygen by parents who experienced            desired number of patients in our sample-size calcula-
home management were because of specific concerns              tion. This occurred for 2 main reasons. ED census was
about the complexity of home oxygen use before dis-           beginning to outstretch inpatient bed availability; there-
charge, the use of highly trained respiratory therapists to   fore, many patients with bronchiolitis were being dis-
explain home care, and prearranged follow-up with             charged on oxygen from the ED outside of the study.
their PCP. Caregivers of admitted patients did not receive    The hospital was also in the process of developing a
this education; thus, they may prefer inpatient admis-        short-stay unit distinct from the ED observation unit to
sion because of misgivings and misconceptions about the       attempt to meet the needs of this patient population.
challenges of the use of home oxygen, although 79% of         Therefore, the decision was made to stop the study pro-
the hospitalized patients were eventually discharged          tocol, and additional attempts to restart the study were
from the hospital on home oxygen. It is also interesting      unsuccessful.
to note that 45% of the parents who were randomly                Our sample size is small, and we cannot make state-
assigned to home oxygen felt that the observation period      ments about safety of discharge on home oxygen, opti-
of 8 hours was too long, and only 1 patient (3%) felt it      mal observation time period, or criteria that might pre-
was too short. Although we did not attempt to ascertain       dict which patients might fail and require hospital
why, this feeling could be because of adequate explana-       admission. A next step will be to systematically follow all
tion and education about home oxygen, the fact that the       of the patients discharged from the ED on home oxygen
majority of the patients did well, and could be reflective     for adverse events and need for subsequent hospitaliza-
of a high acceptance by families of home therapies. We        tion.
developed conservative inclusion criteria including the
availability of transportation to return at 24 and 48         CONCLUSIONS
hours after discharge, a contact telephone number, liv-       This is the first study to demonstrate discharge home
ing no more than 30 minutes from an emergency med-            from the ED with supplemental oxygen in patients with
ical facility, and a smoke-free environment to maximize       bronchiolitis. We found that an 8-hour observation pe-
the safety of discharge home.                                 riod identifies those patients who may resolve their ox-


                                                                               PEDIATRICS Volume 117, Number 3, March 2006   639
              Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
ygen requirement and those who may worsen and re-                        8. Thilo EH, Comito J, McCulliss D. Home oxygen therapy in the
quire hospital admission, and, because of a low                             newborn. Costs and parental acceptance. Am J Dis Child. 1987;
                                                                            141:766 –768
incidence of complications, the 8-hour observation pe-
                                                                         9. Gracey K, Talbot D, Lankford R, Dodge P. The changing face of
riod is an option for management. High acceptance rates                     bronchopulmonary dysplasia: part 2. Discharging an infant
by caregivers and PCPs supports this approach. Addi-                        home on oxygen. Adv Neonatal Care. 2003;3:88 –98
tional study is necessary to determine safety and eco-                  10. Wilson DF, Horn SD, Hendley O, Smout R, Gassaway J. Effect
nomic impact.                                                               of practice variation on resource utilization in infants for viral
                                                                            lower respiratory illness. Pediatrics. 2001;108:851– 855
ACKNOWLEDGMENTS                                                         11. Weiss J, Annamalai VR. Discharge criteria for bronchiolitis
                                                                            patients [letter]. Pediatrics. 2003;111:445
This study was funded by the Children’s Hospital Re-
                                                                        12. Johnson DW, Adair C, Brant R, Holmwood J, Mitchell I. Dif-
search Institute and Kaiser Permanente. Funding was                         ferences in admission rates of children with bronchiolitis by
used to support research assistant time in enrolling pa-                    pediatric and general emergency departments. Pediatrics. 2002;
tients, collecting data, performing telephone follow-up,                    110(4). Available at: www.pediatrics.org/cgi/content/full/110/
and entering data.                                                          4/e49
   Lalit Bajaj had full access to all of the data in the study          13. Plint AC, Johnson DW, Wiebe N, et al. Practice variation
                                                                            among pediatric emergency departments in the treatment of
and takes responsibility for the integrity of the data and
                                                                            bronchiolitis. Acad Emerg Med. 2004;11:353–360
the accuracy of the data analysis.                                      14. Christakis DA, Cowan CA, Garrison MM, Molteni R, Marcuse
                                                                            E, Zerr DM. Variation in inpatient testing and management of
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    Eur J Pediatr. 1997;156:878 – 882                                       MM. Randomized trial of salbutamol in acute bronchiolitis.
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640    BAJAJ, et al
                  Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
A Randomized Trial of Home Oxygen Therapy From the Emergency
                    Department for Acute Bronchiolitis
                Lalit Bajaj, Carol G. Turner and Joan Bothner
                        Pediatrics 2006;117;633-640
                        DOI: 10.1542/peds.2005-1322
Updated Information               including high-resolution figures, can be found at:
& Services                        http://www.pediatrics.org/cgi/content/full/117/3/633
References                        This article cites 20 articles, 9 of which you can access for free
                                  at:
                                  http://www.pediatrics.org/cgi/content/full/117/3/633#BIBL
Citations                         This article has been cited by 6 HighWire-hosted articles:
                                  http://www.pediatrics.org/cgi/content/full/117/3/633#otherarticle
                                  s
Post-Publication                  One P3R has been posted to this article:
Peer Reviews (P3Rs)               http://www.pediatrics.org/cgi/eletters/117/3/633
Subspecialty Collections          This article, along with others on similar topics, appears in the
                                  following collection(s):
                                  Respiratory Tract
                                  http://www.pediatrics.org/cgi/collection/respiratory_tract
Permissions & Licensing           Information about reproducing this article in parts (figures,
                                  tables) or in its entirety can be found online at:
                                  http://www.pediatrics.org/misc/Permissions.shtml
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Home oxygen therapy trial for acute bronchiolitis

  • 1. A Randomized Trial of Home Oxygen Therapy From the Emergency Department for Acute Bronchiolitis Lalit Bajaj, Carol G. Turner and Joan Bothner Pediatrics 2006;117;633-640 DOI: 10.1542/peds.2005-1322 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://www.pediatrics.org/cgi/content/full/117/3/633 PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2006 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275. Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 2. ARTICLE A Randomized Trial of Home Oxygen Therapy From the Emergency Department for Acute Bronchiolitis Lalit Bajaj, MD, MPHa, Carol G. Turner, MDb, Joan Bothner, MDa aDepartment of Pediatrics, Section of Emergency Medicine, University of Colorado Health Sciences Center/Children’s Hospital, Denver, Colorado; bAspen Park Pediatrics, Conifer, Colorado The authors have indicated they have no financial relationships relevant to this article to disclose. ABSTRACT OBJECTIVE. Hypoxia is a common reason for hospital admission in infants and chil- dren with acute bronchiolitis. No study has evaluated discharge from the emer- www.pediatrics.org/cgi/doi/10.1542/ gency department (ED) on home oxygen. This study evaluated the feasibility and peds.2005-1322 safety of ED discharge on home oxygen in the treatment of acute bronchiolitis. doi:10.1542/peds.2005-1322 METHODS. This was a prospective, randomized trial of infants and children with acute Key Words bronchiolitis, hypoxia, oxygen, home bronchiolitis and hypoxia (room-air saturations of Յ87%) aged 2 to 24 months therapy, observation presenting to an urban, academic, tertiary care children’s hospital ED from De- Abbreviations cember 1998 to April 2001. Subjects received inpatient admission or home oxygen PCP—primary care provider after an 8-hour observation period in the ED. We measured the failure to meet ED— emergency department RDSS—respiratory distress severity score discharge criteria during the observation period, return for hospital admission, and Accepted for publication Jul 22, 2005 incidence of serious complications. Address correspondence to Lalit Bajaj, MD, MPH, Department of Pediatrics/Section of RESULTS. Ninety-two patients were enrolled. Fifty three (58%) were randomly as- Emergency Medicine, University of Colorado signed to home and 39 (42%) to inpatient admission. There were no differences Health Sciences Center/Children’s Hospital, 1056 E 19th Ave B251, Denver, CO 80218. E- between the groups in age, initial room-air saturation, and respiratory distress mail: bajaj.lalit@tchden.org severity score. Of 53 patients, 37 (70%) randomly assigned to home oxygen PEDIATRICS (ISSN Numbers: Print, 0031-4005; completed the observation period and were discharged from the hospital. The Online, 1098-4275). Copyright © 2006 by the American Academy of Pediatrics remaining 16 patients were excluded from the study (6), resolved their oxygen requirement (5), or failed to meet the discharge criteria and were admitted (5). One discharged patient (2.7%) returned to the hospital and was admitted for a cyanotic spell at home after the 24-hour follow-up appointment. The patient had an uncomplicated hospital course with a length of stay of 45 hours. The remaining 36 patients (97%) were treated successfully as outpatients with home oxygen. Satisfaction with home oxygen was high from the caregiver and the primary care provider. CONCLUSIONS. Discharge from the ED on home oxygen after a period of observation is an option for patients with acute bronchiolitis. Secondary to the low incidence of complications, the safety of this practice will require a larger study. PEDIATRICS Volume 117, Number 3, March 2006 633 Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 3. B RONCHIOLITIS IS THE most common cause of hospital admission in children Ͻ1 year of age. An estimated 80 000 to 120 000 children Ͻ1 year of age are admitted fined as (1) not requiring transfer to the intensive care unit (ICU), (2) not being readmitted to the hospital after discharge, and (3) not having any serious complications. annually. Hospitalization rates have been increasing dra- Serious complications were defined as respiratory arrest, matically, with estimates of an increase of 239% in apnea, cyanotic spell, and respiratory failure. The success children Ͻ6 months from 1980 to 1996.1 One of the rate for hospitalized patients was estimated at 99%. Us- hypotheses for this dramatic increase is the almost uni- ing a minimum success rate of 90% for home oxygen, versal use of pulse-oximetry screening and the imple- we estimated that ϳ160 patients (80 in each group) mentation of an oxygen-saturation cut off that warrants would be needed with an ␣ value of .05 and a ␤ value of hospital admission for supplemental oxygen. The need .20. for supplemental oxygen therapy in a previously healthy Patients were enrolled over 3 consecutive winter sea- patient is considered by many to require mandatory sons from December 1998 to April 2001 at an urban, admission and is included as one of the therapies defin- academic, tertiary care children’s hospital at an elevation ing mandatory admission in studies evaluating a pediat- of 5280 ft (1609 m). All of the patients received deep ric risk of admission score.2,3 It has also been demon- nasal suctioning and 2 albuterol treatments (2.5 mg) via strated that physicians use the oxygen-saturation nebulizer over the first 60 minutes. All of the patients information frequently to determine whether a patient had their respiratory distress severity score (RDSS) (Ta- requires hospital admission.4 A recent study addressed ble 1) documented at the start of the study, after suc- how often patients remain in the hospital only for sup- tioning, and after the nebulizer treatments. The RDSS plemental oxygen after other clinical parameters (oral has 4 categories: respiratory rate, wheezing, aeration, intake and work of breathing) have improved and found and retractions, and each category has a scoring system that 26% of patients have a prolonged stay of an average of 0, 1, or 2 points. The total score is obtained by adding of 1.6 days.5 the score from each category. All of the patients then In the years preceding this study, community primary received a chest radiograph, and, if read by the attending care providers (PCPs) were faced with a rapidly expand- radiologist as consistent with an acute bacterial pneu- ing population of children and a large burden of patients monia, the patient was not approached for enrollment in with bronchiolitis requiring oxygen. Hospital beds the study. around the community were becoming very difficult to Caregivers were approached during times at which a find, and the practice of arranging home oxygen from research assistant was available to assess whether they the office setting began to emerge. This was especially met the inclusion criteria or had any of the exclusion true in practices that had close relationships with their criteria (Table 2). Informed consent was obtained, and patients and felt comfortable that if any deterioration patients were randomly assigned to traditional inpatient occurred, the caregivers would quickly notify them and hospitalization or to home oxygen therapy. Randomiza- present to a local emergency department (ED). To date, tion was performed by using a block-randomization ta- there are no publications evaluating the use of home ble created before the start of the study. Research assis- oxygen therapy from the ED or the primary care clinic in tants were blinded to allocation at the time of patients with acute bronchiolitis requiring supplemental enrollment. The study packet with the assignment could oxygen. We undertook a prospective, randomized pilot not be opened until informed consent had been ob- study of home oxygen from the ED compared with tained. Patients randomly assigned to the inpatient arm traditional inpatient hospitalization to assess for the fea- of the study had an RDSS recorded every 2 hours for the sibility and safety of this practice. first 8 hours of hospitalization. Other treatments in the hospital were at the discretion of the inpatient attending, METHODS and the families were contacted at 1 week by telephone We conducted a prospective, randomized trial of tradi- and were asked to answer questions from a standardized tional inpatient hospitalization versus home oxygen questionnaire. A chart review was also performed to from the ED in a convenience sample of patients with extract hospital complications and length of stay data. acute bronchiolitis and hypoxia. In preparation for con- Patients randomly assigned to the home oxygen arm ducting the study, we sent out information letters to all PCPs who refer patients to our ED to let them know what the study would require of them if a patient in TABLE 1 RDSS their practice was enrolled. Score Respiratory Rate Wheezing Aeration Retractions A sample-size calculation was performed before the 0–1 y 1–2 y start of the study. The success of the home oxygen 0 20–40 15–30 None All fields None protocol was defined as (1) not requiring hospitalization 1 41–55 31–45 Mild-Exp Ն4 fields Mild after ED discharge and (2) not having any serious com- 2 Ͼ55 Ͼ45 Insp and Exp Ͻ4 fields Marked plications. Success with hospitalized patients was de- Total score: 0 – 4, mild; 5–7, moderate; Ͼ8, severe. 634 BAJAJ, et al Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 4. TABLE 2 Inclusion/Exclusion Criteria Inclusion criteria 2–24 mo, minimum of 44 wk after conceptional age Clinical diagnosis of bronchiolitis defined as an acute respiratory illness associated with nasal congestion, cough, diffuse wheezing or crackles, and tachypnea or retractions Chest radiograph consistent with viral bronchiolitis First episode of wheezing Room-air saturation of Յ87% on arrival to the ED Family has transportation to return to PCP or ED 24 and 48 h after discharge from the ED Lives at altitude Յ6000 ft (1829 m) Lives Յ30 min from an emergency medical facility Caregivers must maintain a smoke-free environment defined as no smoking in house or car Caregivers must have a contact telephone number Exclusion criteria Preexisting cardiac, pulmonary (including bronchopulmonary dysplasia), neuromuscular, or nutritional (including failure to thrive) disorders and preexisting congenital or acquired airway anomalies Ͻ44 wk after conceptional age History of apnea Acute bacterial pneumonia as defined as a focal infiltrate on chest radiograph Prior episode of wheezing Room-air saturations Ͼ87% No available transportation for follow-up visits Lives at altitude Ͼ6000 ft (1829 m) Lives Ͼ30 min from health care facility Steroid administration Caregivers unable to stay with patient in observation unit of the study were placed in the ED observation unit for an 8-hour observation period. Standard observation consisted of continuous pulse oximetry and vital-sign checks every 2 hours. An RDDS was assigned every 2 hours. Four separate pulse-oximetry measurements were recorded while on oxygen (asleep and feeding were mandatory). At the end of the observation period, the following defined discharge criteria had to be met: saturations of Ն90% on Յ1 L/min nasal cannula oxygen while the patient was awake, asleep, and feeding; the FIGURE 1 patient must be able to maintain hydration; the patient Treatment protocol. must have no signs of deteriorating respiratory status; the attending physician and caregiver must be comfort- able with discharge; and 24-hour follow-up must be incidence of serious complications. Secondary outcome arranged. Patients were taught the operation of the por- measures were caregiver satisfaction, caregiver prefer- table home oxygen unit and were given the unit before ence, PCP satisfaction, and PCP preference. discharge. Patients were discharged on Յ1 L nasal can- Data were analyzed by using SPSS 12.0 (SPSS Inc, nula oxygen. Chicago, IL). Differences between groups were analyzed Standardized questionnaires were completed by the by the Student’s t test for continuous variables and the PCP at the 24- and 48-hour visit and were faxed back to ␹2 test for categorical variables. This study was approved the study coordinator. At 72 hours, a telephone fol- by the Colorado Multiple Institutional Review Board low-up questionnaire was administered to both the PCP and the Kaiser Permanente Institutional Review Board. and the caregiver. A 1-week telephone follow-up ques- tionnaire was also administered to the caregiver. Fig 1 RESULTS displays the treatment protocol. Ninety-two patients were enrolled over 3 consecutive Primary outcome measures included failure to meet bronchiolitis seasons. A modified consolidated standards discharge criteria during the observation period, return of reporting trials diagram is presented in Fig 2. These for hospital admission after successful discharge, and patients had a mean age of 7.8 months, a mean room-air PEDIATRICS Volume 117, Number 3, March 2006 635 Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 5. TABLE 3 Demographics/Clinical Characteristics of Randomized Patients (n ‫)29 ؍‬ Characteristic Overall Home Inpatient P (n ϭ 92) (n ϭ53) (n ϭ 39) Age, mo Mean 7.8 7.6 8.2 .606a Range 2–23 2–21.4 2.1–23 Gender, n (%) Male 52 (57) 29 (55) 23 (59) .424b Female 40 (43) 24 (45) 16 (41) Maternal age, y Mean 27.06 26.68 27.59 .541a Range 16–43 18–43 16–43 Initial RDSS Mean 4.23 4.13 4.43 .366a Initial room-air saturation, 85.0 84.3 85.8 .208a mean, % 8-h RDSS, mean 2.28 2.31 2.25 .876a 8-h O2 required, L/min Mean 0.485 0.436 0.560 .037a Range 0.125–1 0.125–1 0.125–1 a Student’s t test. b ␹2 test. TABLE 4 Demographics/Clinical Characteristics of Patients FIGURE 2 Completing Study (n ‫)07 ؍‬ Modified consolidated standards of reporting trials diagram. Characteristic Overall Home Inpatient P (n ϭ70) (n ϭ 37) (n ϭ 33) Age, mo saturation of 85%, a mean RDSS of 4.23, and a mean Mean 7.54 7.09 8.02 .438a Range 2–22.4 2–17.4 2–22.4 oxygen requirement of 0.485 L/min. Gender, n (%) Fifty-three patients (58%) were randomly assigned to Male 39 (55.7) 19 (51.4) 20 (60.6) .478b home, and 39 (42%) were randomly assigned to inpa- Female 31 (44.3) 18 (48.6) 13 (39.4) tient admission. There were no differences between the Initial RDSS, mean 4.04 3.72 4.39 .069a groups in age, initial room-air saturation, and initial Initial room-air saturation, 85.1 84.8 85.4 .659a mean, % RDSS. There was a statistically significant difference in 8-h RDSS, mean 2.04 1.86 2.25 .262a the amount of oxygen required at 8 hours for the pa- 8-h O2 required, L/min tients who had been admitted versus those who were Mean 0.492 0.434 0.563 .013a discharged (Table 3). These relationships remained the Range 0.125–1 0.125–1 0.125–1 same when patients completing the study were analyzed a Student’s t test. b ␹2 test. (Table 4). Based on the actual number of patients en- rolled and a success rate of 99% in the hospitalized patients, we would detect an 80% success rate in the home oxygen patients as a statistically significant differ- tion period and were discharged with no supplemental ence. oxygen. These 5 patients did not return to the study Of the 53 patients, 37 (70%) randomly assigned to institution in the following week for any additional care. home oxygen completed the observation period and The remaining 5 patients did not meet discharge criteria were discharged from the hospital. Six patients (11.3%) and were subsequently admitted to the hospital for fur- failed to complete the observation period: 2 patients ther care: 2 patients had concerns from the nursing staff were diagnosed with pneumonia from their chest radio- and attending physician for inadequate oral intake, 2 graph that was obtained after enrollment instead of be- patients had concerns for increased work of breathing, fore randomization, 3 withdrew secondary to caregiver and 1 patient was given a change in diagnosis to reactive anxiety, and 1 was excluded secondary to transfer from airways disease and was given oral corticosteroids. Thir- another facility, which did not allow for the ascertain- ty-seven patients were successfully sent home with ment of initial data. home oxygen. Ten patients completed the observation period but One patient (2.7%; 95% confidence interval: 0.6 – were unable to complete the remainder of the study: 5 13.8%) of the 37 discharged from the ED returned to the resolved their oxygen requirement during the observa- hospital and was admitted for a cyanotic spell at home 636 BAJAJ, et al Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 6. after the 24-hour follow-up appointment. This was a 1 patient resolved the oxygen requirement before reach- 4-month-old who was sent to the ED from the 24-hour ing the inpatient bed, 1 family became uncomfortable follow-up visit with a history of a possible cyanotic spell with being in a research study, and 2 patients had in- at home. The patient had an uncomplicated hospital complete medical charts for review. The patient dis- course with a length of stay of 45 hours. This is the only charged who no longer required supplemental oxygen patient who had a serious complication in the study. The did not return in the following week for additional care remaining 36 patients (97%; 95% confidence interval: to the study institution. The remaining 33 patients were 86 –99%) were treated successfully as outpatients with available for analysis. home oxygen therapy. The hospitalized patients had a mean length of stay of Of the 37 patients, 33 (89%) had a 24- or 48-hour 1.8 days, with a range of 0.58 to 6.3 days. Five of the survey completed by their PCP; 33 (89%) had a com- patients (15.2%) had a hospital stay of Ͼ3 days (Table pleted 72-hour telephone follow-up; and 35 (95%) had 6). Of these 5 patients, 2 were diagnosed with pneumo- a completed 1-week telephone follow-up. All 37 (100%) nia on subsequent chest radiograph, and 1 was diag- of the patients had at least 1 of the 3 follow-up surveys nosed with pneumonia and required intravenous fluids. completed (Table 5). One patient was a former 29-week infant who had no At the 24/48-hour follow-up, 97% of the caregivers complications noted, and the remaining patient had no were satisfied with their child at home, and 94% of the complications noted. Twenty six of the patients (79%) PCPs were satisfied with the patient being at home. At were discharged from the inpatient medical service on the 72-hour telephone follow-up we asked about pref- home oxygen. There were no patients who required erence, and 79% of the caregivers stated that they pre- transfer to the ICU, and there were no readmissions ferred to be at home, and 15% of the caregivers would within 1 week after discharge. All 33 of the patient’s have preferred to be in the hospital. Sixty-four percent caregivers were successfully contacted at the 1-week of the PCPs stated they preferred their patients to be at telephone follow-up; 36% of the caregivers would have home, whereas 27% of them would have preferred the preferred home care, 49% preferred hospital care, and hospital. At the 72-hour survey, 100% of the caretakers 15% had no opinion (Table 7). felt they had received adequate instruction on the use of Analysis of self-reported data on missed days from home oxygen. Ninety-seven percent (34 of 35) of the work showed a trend in less missed days from work in patients at the 7-day follow-up were satisfied with home the home oxygen group versus the hospitalized group oxygen for their child. Four patients (11%) were still on (mean: 1.72 vs 2.69, respectively). This finding was not oxygen at a week follow-up (Table 5). statistically significant. Thirty-nine patients (42%) were randomly assigned to traditional inpatient hospitalization. Six patients were DISCUSSION excluded from the study: 2 patients were diagnosed with This study describes the discharge on home oxygen from pneumonia from their chest radiograph that was ob- the ED after an 8-hour period of observation of infants tained after enrollment instead of before randomization, with uncomplicated bronchiolitis. This practice is be- TABLE 5 Caregiver/PCP Satisfaction With Home O2 (n ‫)73 ؍‬ Variable 24/48-h Visit 72-h Telephone 7-d Telephone Questionnaire at Questionnaire Questionnaire PCP Office (33 of 37), n (%) (33 of 37), n (%) (35 of 37), n (%) Caregiver satisfied at home 32/33 (97) 31/33 (94) 34/35 (97) Caregiver preference Home 26 (79) Hospital 5 (15) No preference 2 (6) PCP preference Home 21 (64) Hospital 9 (27) No preference 3 (9) PCP satisfaction 31/33 (94) Adequate instruction 33/33 (100) Parent observation length Too short 1 (3) Right 13 (40) Too long 15 (45) No opinion 4 (12) Still on O2 at 1 wk 4/35 (11.4) PEDIATRICS Volume 117, Number 3, March 2006 637 Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 7. TABLE 6 Hospitalized Patients (n ‫)33 ؍‬ with supplemental oxygen for bronchiolitis. Other au- Variable Hospitalized Patients thors have indicated that the management of bronchi- (n ϭ 33) olitis varies widely in both the ED setting, as well as the Length of stay, d inpatient setting, and is not based on clear evidence of Mean 1.83 efficacy of treatment options.12–14 Range 0.58–6.33 The implementation of clinical care pathways have Ͼ3 d of hospitalization, n/N (%) 5/33 (15.2) been shown to decrease ancillary testing and overall cost Discharged on home O2, n/N (%) 26/33 (79) Telephone questionnaire at 7 d, n/N (%) 33/33 (100) and length of stay; however, use of home oxygen after Caregiver preference ED evaluation and observation have not been part of Home, n (%) 12 (36) published guidelines to date.15–18 Hospitalization rates for Hospital, n (%) 16 (49) bronchiolitis have increased 239% over the past 2 de- No opinion, n (%) 5 (15) cades for children Ͻ6 months of age.1 During that time period, mortality rates remained relatively constant.19 This increase in admission frequency has been postu- TABLE 7 Days Missed From Work: Home Versus Hospital lated to relate to perhaps an increased reliance on pulse- Days Home Hospital P oximetry measurements.4 In a retrospective analysis of Missed (n ϭ 37) (n ϭ 33) 62 patients admitted for bronchiolitis, Schroeder et al5 Mean 1.72 2.69 .145a showed that hospitalization was prolonged by an aver- a Student’s t test. age of 1.6 days in 16 patients (26%) because of oxygen- ation concerns based on pulse-oximetry readings after all of the other discharge criteria were met. These pro- coming more common in many sectors of the medical longed hospitalizations are not without potential addi- community and in PCP offices without benefit of mea- tional costs and the risk of adverse events.20 surement of return rates, subsequent ED visit for wors- To enroll patients with uncomplicated cases of bron- ening disease, or hospital admission. The reasons for this chiolitis, we chose to obtain a chest radiograph on all of change in clinical practice are not known but could the patients to exclude possible bacterial pneumonia, reflect a perceived overcrowding of EDs, the belief that foreign bodies, pulmonary edema, and other cardiac or bronchiolitis is a mild disease in most infants, that the respiratory tract abnormalities. Standard care at the time need for oxygen is often the only reason for hospital of our study included deep nasal suction and a trial of admission, ease of care of patients on home oxygen, and beta agonists. We realize that these aspects of bronchi- the fact that home oxygen has become easily accessible olitis care, with the exception of nasal suctioning, may from home health care companies in recent years. no longer be necessary. We used a respiratory distress The use of home oxygen therapy and subsequent score modeled from a previously published respiratory early nursery discharge has been evaluated in the man- distress score to have an objective measure of respiratory agement of premature infants with bronchopulmonary distress to allow for comparison between the 2 groups at dysplasia and chronic lung disease and has been shown enrollment and discharge home.21 However, we did not to be safe and effective, with an associated decrease in incorporate this score as either inclusion or exclusion cost and no increase in morbidity or readmission rates.6,7 criteria or as discharge criteria. The study investigator Families, when surveyed, responded 94% of the time team felt that incorporating an absolute cut-off score for that they would again take an infant home on oxygen, discharge home would be difficult and that the clinical and this practice is now routine.8,9 This approach has not measures listed in the discharge criteria would be more yet become the standard of care for older infants and clinically relevant. children with acute respiratory tract illness. In 2001, Our methodology also included a mandatory 8-hour Wilson et al10 evaluated care for patients Ͻ1 year of age observation period to allow for varying stages of disease admitted with bronchiolitis in 10 children’s medical cen- at the time of enrollment. This observation period ters and found that care varied widely, that variations proved to be of significant benefit and affected care in 10 could not be explained by difference in disease severity, (21%) of 47 patients. Five patients were found to no and that there was no evidence that a greater intensity of longer require supplemental oxygen and were dis- care affected morbidity or mortality. The use of home charged from the hospital. These patients were an un- oxygen was not measured. In a letter to the editor of expected finding. We removed the patients from the Pediatrics concerning this publication, Weiss and Anna- study at that time, because it did not seem reasonable to malai11 queried the issue of standardized discharge cri- require these families to adhere to the stringent fol- teria from the hospital for patients with bronchiolitis. low-up requirements. They did receive standard bron- They report on a survey of chief residents at 30 chil- chiolitis discharge instructions to return immediately for dren’s hospitals, and, of the 17 responses, only 2 hospi- any concern of increased work of breathing, cyanosis, tals reported that they routinely send patients home poor feeding, or any other concerns. Because these pa- 638 BAJAJ, et al Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 8. tients were observed for an extended period of time and Bronchiolitis is the most common cause of lower were found to be hypoxic at the start of their evaluation, respiratory disease that requires hospital admission and we performed chart review on these patients, and none contributes significantly to health care costs.22 Home of them returned to the study institution in the follow- management may decrease these costs, as has been dem- ing week for additional care. The remaining 5 patients onstrated with infants discharged on home oxygen from were subsequently admitted to the hospital. None of the newborn nursery. Although it did not reach signifi- these patients were transferred to the ICU. Only 1 pa- cance, we also demonstrated a trend toward less missed tient was readmitted for a questionable cyanotic episode days of work for families who were randomly assigned to at home and experienced no additional episodes during home therapy. Family economic impact, ability to com- the subsequent 45-hour inpatient admission. ply with prescribed care plans, and overall acceptance of Our sample size is too small to evaluate the ideal home oxygen therapy for acute respiratory disease in period of observation, although the 8-hour time period infants and children has not been fully evaluated and we chose allowed some patients to improve and identi- warrants further study. fied some patients that failed. Our results do support the Our study has several limitations. This is a conve- use of an observation period rather than immediate nience sample of patients who presented with bronchi- discharge after evaluation and diagnosis. olitis, and we have no information on patients who were Our study showed high rates of caregiver and PCP not enrolled; in addition, there is the potential of selec- satisfaction with both inpatient admission and discharge tion bias. Patients who required higher levels of oxygen, after observation in the ED on home oxygen therapy. presented with more respiratory distress, or did not at Only 15% of the caregivers of the patients discharged first impression seem to have a good home environment from the ED on oxygen therapy at the time of the may have been excluded. Our patient population is also 72-hour follow-up questionnaire stated that they would a referred population, so it may not be reflective of have preferred hospital admission, whereas 36% of care- patients who present to other sites of care such as a givers of the hospitalized patients would have preferred primary care clinic or office. Caregivers and ED physi- to have been treated at home. Forty-nine percent of the cians were not blinded to which treatment arm the caregivers of the hospitalized patients preferred hospital patient was assigned, which may have affected treat- admission. The preference for home treatment was ment decisions. Our strict inclusion and exclusion crite- higher among caregivers than among PCPs. PCPs of the ria, as well as the performance of the study at an altitude patients discharged from the ED would have preferred of 5280 ft (1609 m), limit the external validity of the hospital admission 27% of the time. The reason for this results. is unclear. We feel that the comfort level and preference The study was stopped before the enrollment of the for discharge on oxygen by parents who experienced desired number of patients in our sample-size calcula- home management were because of specific concerns tion. This occurred for 2 main reasons. ED census was about the complexity of home oxygen use before dis- beginning to outstretch inpatient bed availability; there- charge, the use of highly trained respiratory therapists to fore, many patients with bronchiolitis were being dis- explain home care, and prearranged follow-up with charged on oxygen from the ED outside of the study. their PCP. Caregivers of admitted patients did not receive The hospital was also in the process of developing a this education; thus, they may prefer inpatient admis- short-stay unit distinct from the ED observation unit to sion because of misgivings and misconceptions about the attempt to meet the needs of this patient population. challenges of the use of home oxygen, although 79% of Therefore, the decision was made to stop the study pro- the hospitalized patients were eventually discharged tocol, and additional attempts to restart the study were from the hospital on home oxygen. It is also interesting unsuccessful. to note that 45% of the parents who were randomly Our sample size is small, and we cannot make state- assigned to home oxygen felt that the observation period ments about safety of discharge on home oxygen, opti- of 8 hours was too long, and only 1 patient (3%) felt it mal observation time period, or criteria that might pre- was too short. Although we did not attempt to ascertain dict which patients might fail and require hospital why, this feeling could be because of adequate explana- admission. A next step will be to systematically follow all tion and education about home oxygen, the fact that the of the patients discharged from the ED on home oxygen majority of the patients did well, and could be reflective for adverse events and need for subsequent hospitaliza- of a high acceptance by families of home therapies. We tion. developed conservative inclusion criteria including the availability of transportation to return at 24 and 48 CONCLUSIONS hours after discharge, a contact telephone number, liv- This is the first study to demonstrate discharge home ing no more than 30 minutes from an emergency med- from the ED with supplemental oxygen in patients with ical facility, and a smoke-free environment to maximize bronchiolitis. We found that an 8-hour observation pe- the safety of discharge home. riod identifies those patients who may resolve their ox- PEDIATRICS Volume 117, Number 3, March 2006 639 Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 9. ygen requirement and those who may worsen and re- 8. Thilo EH, Comito J, McCulliss D. Home oxygen therapy in the quire hospital admission, and, because of a low newborn. Costs and parental acceptance. Am J Dis Child. 1987; 141:766 –768 incidence of complications, the 8-hour observation pe- 9. Gracey K, Talbot D, Lankford R, Dodge P. The changing face of riod is an option for management. High acceptance rates bronchopulmonary dysplasia: part 2. Discharging an infant by caregivers and PCPs supports this approach. Addi- home on oxygen. Adv Neonatal Care. 2003;3:88 –98 tional study is necessary to determine safety and eco- 10. Wilson DF, Horn SD, Hendley O, Smout R, Gassaway J. Effect nomic impact. of practice variation on resource utilization in infants for viral lower respiratory illness. Pediatrics. 2001;108:851– 855 ACKNOWLEDGMENTS 11. Weiss J, Annamalai VR. Discharge criteria for bronchiolitis patients [letter]. Pediatrics. 2003;111:445 This study was funded by the Children’s Hospital Re- 12. Johnson DW, Adair C, Brant R, Holmwood J, Mitchell I. Dif- search Institute and Kaiser Permanente. Funding was ferences in admission rates of children with bronchiolitis by used to support research assistant time in enrolling pa- pediatric and general emergency departments. Pediatrics. 2002; tients, collecting data, performing telephone follow-up, 110(4). Available at: www.pediatrics.org/cgi/content/full/110/ and entering data. 4/e49 Lalit Bajaj had full access to all of the data in the study 13. Plint AC, Johnson DW, Wiebe N, et al. Practice variation among pediatric emergency departments in the treatment of and takes responsibility for the integrity of the data and bronchiolitis. Acad Emerg Med. 2004;11:353–360 the accuracy of the data analysis. 14. Christakis DA, Cowan CA, Garrison MM, Molteni R, Marcuse E, Zerr DM. Variation in inpatient testing and management of REFERENCES bronchiolitis. Pediatrics. 2005;115:878 – 884 1. Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Ander- 15. Perlstein PH, Kotagal UR, Bolling C, et al. Evaluation of an son LJ. Bronchiolitis-associated hospitalizations among US evidence-based guideline for bronchiolitis. Pediatrics. 1999;104: children, 1980 –1996. JAMA. 1999;282:1140 –1446 1334 –1341 2. Chamberlain JM, Patel KM, Ruttimann UE, Pollack MM. Pe- 16. Perlstein PH, Kotagal UR, Schoettker PJ, et al. Sustaining the diatric risk of admission (PRISA): a measure of severity of implementation of an evidence-based guideline for bronchioli- illness for assessing the risk of hospitalization from the emer- tis. Arch Pediatr Adolesc Med. 2002;154:1001–1107 gency department. Ann Emerg Med. 1998;32:161–169 17. Todd J, Bertoch D, Dolan S. Use of a large national database for 3. Chamberlain JM, Patel KM, Pollack MM. The pediatric risk of comparative evaluation of the effect of a bronchiolitis/viral hospital admission score: a second-generation severity-of- pneumonia clinical care guideline on patient outcome and illness score for pediatric emergency patients. Pediatrics. 2005; research utilization. Arch Pediatr Adolesc Med. 2002;156: 115:388 –395 1086 –1090 4. Mallory MD, Shay DK, Garrett J, Bordley WC. Bronchiolitis 18. Kotagal UR, Robbins JM, Kini NM, Schoettker PL, Atherton management preferences and the influence of pulse oximetry HD, Kirschbaum MS. Impact of a bronchiolitis guideline: a and respiratory rate on the decision to admit. Pediatrics. 2003; multisite demonstration project. Chest. 2002;121:1789 –1797 111(1). Available at: www.pediatrics.org/cgi/content/full/111/ 19. Shay DK, Holman RC, Roosevelt GE, Clarke MJ, Anderson LJ. 1/e45 5. Schroeder AR, Marmor AK, Pantell RH, Newman TB. Impact of Bronchiolitis-associated mortality and estimates of respiratory pulse oximetry and oxygen therapy on length of stay in bron- syncytial virus-associated deaths among US children, chiolitis hospitalizations. Arch Pediatr Adolesc Med. 2004;158: 1979 –1997. J Infect Dis. 2001;183:16 –22 527–530 20. Bergman AB. Pulse oximetry, good technology misapplied. 6. Baraldi E, Carra S, Vencato F, et al. Home oxygen therapy in Arch Pediatr Adolesc Med. 2004;158:594 –595 infants with bronchopulmonary dysplasia: a prospective study. 21. Klassen TP, Rowe PC, Sutcliffe T, Ropp LJ, McDowell IW, Li Eur J Pediatr. 1997;156:878 – 882 MM. Randomized trial of salbutamol in acute bronchiolitis. 7. Greenough A, Alexander J, Burgess S, et al. High versus re- J Pediatr. 1991;118:807– 811 stricted use of home oxygen therapy, health care utilization 22. Rietvald A, de Jonge HCC, Polder JJ, et al. Anticipated costs of and the cost of care in chronic lung disease infants. Eur J Pe- hospitalization for respiratory syncytial virus infection in diatr. 2004;163:292–296 young children at risk. Pediatr Infect Dis J. 2004;23:523–529 640 BAJAJ, et al Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010
  • 10. A Randomized Trial of Home Oxygen Therapy From the Emergency Department for Acute Bronchiolitis Lalit Bajaj, Carol G. Turner and Joan Bothner Pediatrics 2006;117;633-640 DOI: 10.1542/peds.2005-1322 Updated Information including high-resolution figures, can be found at: & Services http://www.pediatrics.org/cgi/content/full/117/3/633 References This article cites 20 articles, 9 of which you can access for free at: http://www.pediatrics.org/cgi/content/full/117/3/633#BIBL Citations This article has been cited by 6 HighWire-hosted articles: http://www.pediatrics.org/cgi/content/full/117/3/633#otherarticle s Post-Publication One P3R has been posted to this article: Peer Reviews (P3Rs) http://www.pediatrics.org/cgi/eletters/117/3/633 Subspecialty Collections This article, along with others on similar topics, appears in the following collection(s): Respiratory Tract http://www.pediatrics.org/cgi/collection/respiratory_tract Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: http://www.pediatrics.org/misc/Permissions.shtml Reprints Information about ordering reprints can be found online: http://www.pediatrics.org/misc/reprints.shtml Downloaded from www.pediatrics.org. Provided by Indonesia:AAP Sponsored on September 29, 2010