1. Oxygenterapi i Norden och i
världen
Thomas Ringbæk, Hjerte-lungemed. afd. Hvidovre, København
2. Overview
Types of home oxygen therapies (terminology)
Evidence: a) COT
b) STOT (unstable condition)
c) SBOT (short burst of oxygen)
d) NOT (nocturnal oxygen)
e) ambulatory & portable oxygen
How do we do in practice?
Home Oxygen Therapy in various countries:
a) guidelines
b) practice/organisation
c) quality
d) prevalence/incidence
e) survival
5. COT in COPD: effect on survival
PaO2 <7.3 kPa;7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa; Stabile and optimal treated; Non-smokers
MRC NOTT
N 87 203
Age 58 66
Men% 76 80
FEV1% 30 30
PO2, 6.8 6.8 kPa
PCO2 7.2 6.9 kPa
Htc.% 52 47
Smoking 45% ?
Flow 2 1-3+1
Hours 13.5 17.7/12
Mobile - +/-
6. COT in non-COPD
Lung fibrosis: 62 patients. No effect on survival.
Unpublished data.
Crockett AJ et al. Domiciliary oxygen for interstitial lung
disease. Cochrane Database Syst Rev 2001; 3:CD002883
7. RCT on moderate hypoxaemic
COPD patients
1987-92 in Poland1987-92 in Poland
135 COPD patients with P135 COPD patients with PaaOO22 7.4-8.7 kPa.7.4-8.7 kPa.
Post-PO2 >8.7 kPa (mean 9.9 kPa)Post-PO2 >8.7 kPa (mean 9.9 kPa)
>17 hrs/day vs. no oxygen (used 13½ hrs)>17 hrs/day vs. no oxygen (used 13½ hrs)
Only concentratorOnly concentrator
Not assessed:Not assessed:
QoLQoL
Daily activity/exerciseDaily activity/exercise
HospitalisationHospitalisation
8. RCT on moderate hypoxaemic
COPD patients (planned study)
3.200 COPD pts. in USA3.200 COPD pts. in USA
Usual careUsual care
Sat.OSat.O22 89-93%:89-93%:
LTOT+ portable oxygenLTOT+ portable oxygen
Outcomes: QoLOutcomes: QoL
Daily activity/exerciseDaily activity/exercise
SurvivalSurvival
10. STOT (oxygen at home while unstable)
Re-evaluation:
1 month later: normalised in 30%1
and 70%2
2-3 months later: 30-50% normalised1,3
PO2<6.7 kPa: only 1 of 23 normalised1
Despite LTOT: 17% died <2 months4
No RCT
1) Levi-Valensi et al. Am Rev Respir Dis 1986
2) Andersson et al. Respir Med 2002
3) NOTT study
4) Eaton et al. Respir Med 2001
12. SBOT
(palliation of attacks of dyspnoea)
Very few studies1,2
Only mentioned superficially in BTS, ATS, GOLD
COPD: 6-12 wks: 4 studies (PO2 8.5-10 kPa):
2 showed a small effect compared to air.
Cancer:
+hypoxaemia at rest: 5 L O2/min > air.
- hypoxaemia at rest: 4 L O2/min= 4 L air/min
1) Booth S et al.Respir Med 2004
2) Booth S et al. Am J Respir Crit Care Med 1996
15. Rationale for Nocturnal Oxygen Therapy
Appr. 30% had nocturnal desat.1
Assoc. with ↑Pulm.AP & ↑mortality2,3
In the NOTT was correction of 7 hours hypoxaemia
related to ↑survival
1) Fletcher EC et al. Chest 1987
2) Fletcher EC et al. ARRD1989
3) Fletcher EC et al. Chest 1992
16. Effects of Nocturnal Oxygen Therapy
Chaouat A et al. Eur Respir J 2001
35 desat. (>30% time with
desat <90%)
Vs. 29 non-desat
19. Aims of portable and ambulatory oxygen
Portable Oxygen (hypoxaemic at rest)
↑hrs on oxygen
↑daily activity
Ambulatory Oxygen (normoxaemic at rest)
Desaturate and/or dyspnoea during exercise
↑exercise tolerance/daily activity
20. Portable oxygen in 159 COPD pts on COT
France 1984-6; presc. >15 hrs/day; 12 MWD>200 m
Flow: 1.7 L/min at rest and 2.2 L/min during exercise. Randomised.
Gr.A=75Gr.A=75 Gr.B=84Gr.B=84
CConc.onc. Conc+small cyl.*(51)Conc+small cyl.*(51) Liquid(33)Liquid(33)
12MWD –O12MWD –O22 407 m407 m 337337 (423)(423) 546546
12MWD+O12MWD+O22 485 m485 m 370370 (478)(478) 628628
Hrs/day:Hrs/day: 14 hrs14 hrs 17 hrs17 hrs (B1 = B2) <0,01(B1 = B2) <0,01
Outdoor with OOutdoor with O22:: 55%55% 67%67%
Indoor:Indoor: equalequal
Activity indoor:Activity indoor: equalequal
Activity outdoor:Activity outdoor: equalequal
25% did not use portable oxygen, and 15% only indoor.25% did not use portable oxygen, and 15% only indoor.
Too heavy according to the patient: Cyl.: 50%, Liquid: 33%Too heavy according to the patient: Cyl.: 50%, Liquid: 33%
*) 2½ L cyl. + stroller (used by 10% of the pts) Vergeret J. Eur Respir J
21. Portable oxygen in 15 COPD pts on COT
London; <1992; oxygen ⇒ +10% exercise tolerance and/or ↓dyspnoea;
Flow: 2 L/min. 8 weeks; randomised and cross-over.
Cylinders(2½-3½ kg) Liquid
6MWD t=0 255 m (median) 250 m
8 wks on O2: equal
Dyspnoea after walk equal
Usage of oxygen: 10 hrs/wk 23,5 hrs/wk*
Outdoor activity: 15 hrs/wk 19,5 hrs/wk*
Preferred by patient: 4 11
QoL (CRQ): equal
Usage of stationary O2: 114 hrs/wk 99,6 hrs/wk
Sum of usage: equal (appr. 17 hrs/day)
Lock SH. Thorax 1992
22. Effect and usage of portable oxygen in
COPD pts on COT
COT: 3-12 months
Excluded pts. who were not
expected to live > 1 year.
Conc.: 3 mdr. Conc.
+O2: 3 mdr. Conc.+O2:
3 mdr.
Lacasse Y, ERJ 2005
23. Effects and use of portable (2½ kg) oxygen in
24 COPD pts on LTOT. 3 x 3 months
•No effect on QoL and 6 MWD
Lacasse Y, ERJ 2005
24. Portable oxygen in COT patients
The Netherlands 1992; 528 pts. 70% COPD; presc. 15.8 hrs/day; COT >½ år
63% had portable oxygen (19% liquid).
27% had no usage; 16% sporadic usage.
Liquid>Cylinders.
Only about 18% carried the device themselves.
Only 20% used the oxygen outdoors
Kampelmacher MJ el al. Respir Med. 1998
25. Categories of complaints due to COT
The Netherlands; 1992; 528 pts; COT >½ year
0 10 20 30 40 50
Restricted autonomy
Delivery device
Oxygen source
Feeling ashamed
Treatment duration
%
Conc.: 55%
Cyl.: 34%
Liquid:35%
Kampelmacher MJ, Respir Med 1998
81% at least one complaint
Non-compliance
was ass. with
“feeling ashamed“
26. Usage of portable oxygen in 125
COPD patients on COT
OutdoorsOutdoors
65%65%
Not outdoorsNot outdoors
35%35%
Portable oxygenPortable oxygen
(38%)(38%)
48%48% 21%21%
Usage hrs/dayUsage hrs/day 1,321,32 1,131,13
>2 hrs/week,%>2 hrs/week,% 4949 2222
Ringbæk; Respir Med 199927% had no usage27% had no usage
during 3 monthsduring 3 months
27. Portable oxygen in 930 COPD pts on COT
France before 1996; Presc. 16 hrs/day; COT >3 months
Portable oxygen to 30% of 893 ptt. with a concentrator.
Only used by 52% in a 3 months period
Only used outdoor by 4% –
especially those with liquid oxygen
Pepin JL et al. Chest 1996
29. Ambulatory oxygen to pts with desat.
and/or dyspnoea. Prevalence in COPD
10% desaturate ≥4%10% desaturate ≥4%
5.926 COPD pts with FEV5.926 COPD pts with FEV11 1.5-2 L (1)1.5-2 L (1)
32% desaturate ≥4% and32% desaturate ≥4% and ≤≤88%88%
81 COPD pts with FEV81 COPD pts with FEV11 =1,29 (2)=1,29 (2)
1. Hadeli KO et al. Chest 2001;120;88-921. Hadeli KO et al. Chest 2001;120;88-92
2. Knower MT et al.2. Knower MT et al. Arch Intern Med 2001;161:732-6Arch Intern Med 2001;161:732-6
30. The clinical relevance of
desaturation during exercise?
Desat. is poorly assoc. tol 6-MWD and dyspnoeaDesat. is poorly assoc. tol 6-MWD and dyspnoea
1. Mak VH et al. Thorax 1993;48(1):33-81. Mak VH et al. Thorax 1993;48(1):33-8
2. Baldwin DR et al. Respir Med 1995;89(9):599-6012. Baldwin DR et al. Respir Med 1995;89(9):599-601
Pulmonal hypertension, hospitalisation, and mortality?Pulmonal hypertension, hospitalisation, and mortality?
(like nocturnal desaturation)(like nocturnal desaturation)
31. Acute effect of ambul.oxygen
↓Borg dyspnoea score 0.5-1.0
↑Physical tolerance 5-20%
+
Weight of device
Risk of stumbling over the tube
Shamed
-
• No effect of oxygen pre- or post-exercise
Killen JWW, Thorax 2000
Lewis CA, ERJ 2003
McKeon JL, Thorax 1988
Stevenson NJ, Thorax. 2004
32. Effect of ambul. oxygen
Combination with rehabilitation
No effect
Garrod R, Thorax 2000
Emtner M, AJRCCM 2003
Rooyackers JM, ERJ 1997
Wadell K, J Rehabil Med 2001
Puhan MA Respir Res 2004
33. Effect of ambul. oxygen
26 COPD; FEV1 0.9 L; PO2: 7.8-10.9 kPa;
Dyspnoea during exercise; desat. not required
6 wks cross-over; 4 L/min O2 or air; DB
6 wks Air 6 wks O2 P-value
Steps: 30 33 NS
Borg 4.3 4.0 NS
Desat. 4.1% 4.7% NS
CRDQ 86 91 NS
McDonald CF et al. AJRCCM 1995
34. Effect of ambul. oxygen
12-week double blinded randomized cross over study. Desat. ≤88%
4 L/min; 2 kg
Eaton ERJ 2002
35. Acute- and short-term effect of ambul. oxygen
on 6 MWD and (acute) and QoL (short-term)
At the end of the study, 14 of 34 responders (41%) were not
interested in the ambul. oxygen therapy due to side effects.
36. Ambulatory oxygen
Unpublished data
American study stopped before scheduled
Nine months: 22 of 100 expected COPD pts
Inclusion: PO2<60 mmHg (most had >60 mmHg)
Used ambulatory oxygen < 2 hrs/day
37. Danish study on ambulatory
oxygen combined with rehab.
Inclusio criteria: Desat. >4% and less than <90% during
endurance shuttle walk test ESWT (85% of max.)
Interested in using ambulatory oxygen (Freestyle)
Exclusion: COT
Outcomes:
ESWT (pre- and post-rehab, 3, and 6 months)
SGRQ, exacerbations, hospitalisation, mortality, and
usage of oxygen.
26 patients randomised. Planned 110 pts. Only 40% of
eligible pts wanted to participate.
38.
39. International criteria for COT
PaO2 <7.3 kPa (Sat. 88%)
(7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa
Stabile and optimal treatedStabile and optimal treated
Non-smokers
Used >15 hours daily
Follow-up after 3 months and then every
6 months.
40. Start of HOT right after hospitalisation
while patients are clinical unstable
Country Frequency Nationale Guidelines
80% Yes
28% Yes, if PO2<6.7 kPa
? Only stabile?
>4 weeks after hosp.
? Yes
41. Responsible for the treatment
Country Only pulm.
physicians
Pulm. Phys. &
Intern med.
Also GPs
Denmark X
Sweden X
Norway X
UK Specialist
teams
Yes, but checked
by specialist
42. International criteria for COT
PaO2 <7.3 kPa (Sat. 88%)
(7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa
Stabile and optimal treated
Non-smokers
Used >15 hours daily
Follow-up after 3 months and then everyFollow-up after 3 months and then every
6 months.6 months.
43. Follow-up in different countries
Country Adherence
rate
Guidelines
Denmark1
60% 3 wks apart then every ½yr
UK2
61% The same
Norway ? 3 wks then every 3 months
Sweden3
39% 2 wks then every 6 months
1) Ringbaek et al. Respir Med 2006
2) Walshaw MJ et al. BMJ 1988
3) Utsättningsförsök hos KOL-pts startet ved
forsämring
44. Home visits by a respiratory nurse?
Country Available?
Norway Yes
Denmark Most places with pulm.
physicians
Sweden Recommended
UK Recommended and
available many places
45. International criteria for COT
PaO2 <7.3 kPa (Sat. 88%)
(7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa
Stabile and optimal treated
Non-smokersNon-smokers
Used >15 hours daily
Follow-up after 3 months and then every
6 months.
46. Smoking and COT
Effect? Probably
15-24 hrs/day? Not possible for heavy smokers
Safe? Not everybody
Ethical aspects? Seretide to smokers?
47. Effect of oxygen and CO on
12-minute walking distance
Calverley PMA, BMJ 1981
580
600
620
640
660
680
700
720
740
760
Air Oxygen Air+CO Oxygen+CO
12-MWD
meter p<0.01 p<0.01 p<0.01
15 COPD; FEV1=0.56 L; PO2: 5.2-7.7 kPa
48. Tobacco and COT
in different countries
Country Prev. Guidelines
Denmark 21% Consider if PO2<6.7 kPa and
max. 3 cig./day
Sweden 1.1% No
The Netherlands 26% No
Australia 14% No
UK 26% No
Norway ? No
49. International criteria for COT
PPaaOO22 <7.3 kPa (Sat. 88%)<7.3 kPa (Sat. 88%)
(7.3-8.0: EVF>55% or cor pulmonale)(7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa
Stabile and optimal treated
Non-smokers
Used >15 hours daily
Follow-up after 3 months and then every
6 months.
50. Adhere to the hypoxaemic criteria
Country Adherence rate
Denmark 60-70%
France 55-80%
UK 60%
Norway1
2002
2004
2005
44% of 25 pts
66% of 32 pts
35% of 48%
Sweden (2006) 81%2
1) Glittreklinikken; PO2 <7.3 kPa
2) ↑”Bortfall”
51. International criteria for COT
PaO2 <7.3 kPa (Sat. 88%)
(7.3-8.0: EVF>55% or cor pulmonale)
Post-PaO2 >8.6 kPa
Stabile and optimal treated
Non-smokers
Used >15 hours dailyUsed >15 hours daily
Follow-up after 3 months and then every
6 months.
53. Prevalence and Incidence of Home Oxygen
Therapy in Denmark 1994-2006
0
10
20
30
40
50
60
70
80
per100.000
31.10.94 31.12.95 31.12.96 31.12.98 31.12.00 31.12.02 31.12.04 31.12.06
Prevalence
Not known
Others
Cancer
COPD
0
10
20
30
40
50
60
70
80
per100.000
1995 1996 1998 2000 2002 2004 2006
Incidence
Not known
Others
Cancer
COPD
54. Prevalence of HOT in
various countries (per 100.000)
0
10
20
30
40
50
60
70
80
90
100
1987 1993 2006
DK
SE
F
N
55. Prevalence of HOT in
various countries (per 100.000)
0
50
100
150
200
250
1987 1993 2006
DK
SE
F
N
US
56. Prescription of HOT in Denmark
1995 to 2006
0
10
20
30
40
50
60
70
80
90
1995 2002 2006
>15 hrs
Conc.
Liquid
Mobile
%
57. Characteristics of patients on
HOT in Denmark 1995 to 2006
0
10
20
30
40
50
60
70
´95 ´98 ´02 ´06
mean age
%Females
58. Prescription of HOT in Danish
COPD patients 1994 and 2000
0
10
20
30
40
50
60
70
80
90
100
1994 2000
>15 hrs
>1½ L/min
Konc/Flyd
Mobil
59. Oxygen devices in different countries
Country Concentrator Liquid Mobile
unite
Denmark 72 11 58
Sweden 69%
Norway 60% 40%
UK <10 <50%
60. Survival rates of new COPD patients on COT from
Denmark compared to patients from other countries
0
10
20
30
40
50
60
70
80
90
100
0 3 6 9 12 15 18 21 24 27 30 33 36 39
Months
Cumulativesurvivalproportion(%)%)
Denmark (n=5659)
Sweden (n=403)
Belgium (n=270)
France (n=252)
Australia (n=505)
NOTT, COT (n=101)
Japan (n=4552)
61. Bivirkninger/gener:
80-90% har gener, bl.a.:
begrænset livsførelse
irritation ved næsen
udseende (når ude)
Støj fra iltkoncentrator
Udendørs
65%
Ikke udendørs
35%
Mobil ilt (38%) 48% 21%
Anvendt timer/dag 1,32 1,13
27% anvendte ikke ilten
Ringbæk; Respir Med 1999
62. Konklusion
Veldokumenteret effekt ved kronisk
hypoxæmi
De fleste patienter starter efter indl.
Kvaliteten af behandling er dårlig
Mobil ilt ikke tilstrækkelig “mobil”
Lille subgruppe har effekt af ilt ved
anstrengelse.
64. Iltsystemer
Fordele Ulemper
Konc. Ikke dgl. lev. Ditto
“Flytbar” Larmer
“Billig” Strømsvigt
Ingen explosion Problem m. ↑flow
Fylde små flasker
Stålcyl. OK m. ↑flow “Dyr”
(store) Ingen larm Explosionsfare
Uafh. Af strøm Tung & klodset
Dagl. leverance Ditto
65. Iltsystemer
Fordele Ulemper
Flydende Fylder selv Problem m. trapper
den mobile enhed Risiko for forfrysning
Ikke behov for el Udslip
Handy “Dyrt”
Ingen larm
Ingen eksplosion
Højt flow er OK
Stålcyl. OK m. ↑flow Relative tunge
(små) Ingen udslip Eksplosionsfare
Mere udbredt
69. Praktiske forhold ved LTOT
Hvordan ordineres LTOT?
Fugtet luft?
Pulssaturation versus a-punktur?
Rejser inden- og udenlands?
70. Start LTOT
Ca. 80% starter LTOT efter indl.
30-50% har “normaliseret” PO2 efter 3 mdr.
Information
Oxygen-system(er) herunder bærbar ilt
71. Kontrol
Sat. (-OSat. (-O22) (hvis >88%, da a-punktur)) (hvis >88%, da a-punktur)
Bestemme ilt-flowBestemme ilt-flow
Sikre ikke-ryger statusSikre ikke-ryger status
Sikre kompliance (15-24 timer)Sikre kompliance (15-24 timer)
Behov for oxygen-systemerBehov for oxygen-systemer
Evt. hjemme-visitEvt. hjemme-visit
72. Kvaliteten af behandlingen (KOL)
Ca. 20% ryger (måske flere)
Ca. 50% har ikke iltmangel konstant
Ca. 60% ses ambulant
0
10
20
30
40
50
60
70
80
90
100
01.11.9431.12.9531.12.9631.12.9731.12.9831.12.9931.12.00
%
Oxygen
concentrator or
liquid oxygen
15-24 hrs/day
Mobile oxygen
73. Conclusion (1)
↑ incidence and prevalence of COPD
most patients started after hospitalisation
Prescribed 15-24 hrs/day - OK
Only about 50% are followed up
↑ documented hypoxaemia
↓ survival compared to other countries
74. Conclusion (2)
↑ delivered mobile oxygen
Limited use of mobile oxygen. ↑total use
Liquid oxygen, but not cyl., ↑ time outside home
Ambulatory oxygen: +short-term effect but
no/limited long-term effect
Complaints from LTOT are common – especially
restricted autonomy and noise from the conc.
77. Økonomi
Ca.10.000 kr. årligt per pt.
Ca. 4.000 patienter: ca. 40 mill. kr./år
Ca. 3.500 starter hvert år.
78. Effekt af iltterapi på QoL
CRQ (MCID) ∆ Oxygen-air P-value
Dyspnoe (≥3) 2,0 0,02
Fatigue (≥2) 1,8 0,02
Emotionel function (≥3) 3,3 0,006
Mastery (≥3) 1,8 0,008
Total (≥10) 8,8 0,002
79. Hypoxaemia status* in COPD.
Data from the central part of Copenhagen
Nov. 1994 31.12.2000
N=145 N=214
83%
15%
2%
72%
16%
12%
Hypoxaemic
Normoxaemic
Missing
P=0.018*) PO2 <7.3 kPa or 7.3-8.0 kPa
+ clinical signs of chronic hypoxaemia
All Danes: 57.5%
81. Follow-up and ”Sufficient Follow-
up”
0
10
20
30
40
50
60
Follow-up Sufficient follow-
up (n=722)
III 0-10 months
(n=890)
V 1-6 months
(n=533)
%
82. Conclusion (2)
↑ delivered mobile oxygen
Limited use of mobile oxygen. ↑total use
Ambulatory oxygen: +short-term effect but
no/limited long-term effect
Complaints from LTOT are common –
especially restricted autonomy and noise
from the conc.
84. Forbedring af kvaliteten
Bedre iltudstyr
Uddannelse af personale
Information (mundtlig & skriftlig) til pat.
Reglmæssig kontrol
(læge, sygepl., iltleverandør)
1. 135 COPD pts. PO2&gt;60 mmg. Desat. &lt;90% i min. 5 minutter. Des. Havde sign. Lavere PO2 i dagtiden (70 mmHg vs. 75 mmHg)
1. 135 COPD pts. PO2&gt;60 mmg. Desat. &lt;90% i min. 5 minutter. Des. Havde sign. Lavere PO2 i dagtiden (70 mmHg vs. 75 mmHg)
Ikke blindet!
Fransk us (Pepin) var kun 14% generet af støj
Primære effektparametre:
fysisk formåen (endurance shuttle walk time)
måles ved start, efter 7 ugers intensiv lungerehabilitering og efter 3 og 6 måneder
Sekundære effektparametre:
St. George Respiratory Questionnaire (spørgeskema til belysning af helbredsrelateret livskvalitet)
Forbrug af ilt (aflæst koncentrator) efter 7 uger, 3 og 6 måneder
Indlæggelser på sygehus eller skadestuebesøg (antal og tid indtil første event)
Eksacerbationer der har medført behandling med enten antibiotika eller prednisolon
Død (tid indtil event)
Norge 2007: 2400 ptt. + terminal sygdom, hjertelidelse, desaturation.
Sverige: 3800 inkl. Palliativ: 1600 nye (50% palliativ)
In 1994 the prevalence of COPD was about 27/100.000. I the following years, it increased by about 50% to 42/100.000
The incidence of COPD increased from 20 to 25/100.00 during 5 years
In the same sub sample of patients, hypoxaemic status was examined in 1994 and 2000.
In 1994, 72% of the pts had hypoxaemia detected, and this figure increased significantly to 83% in 2000.
However, this sub sample was not representative fo all patients in Denmark. In 1994, 57.5% of all pts. Had hypoxaemia detected.
Compared with the rest of the country, most of the patients in CPH had LTOT prescribed by a chest physician.
434 af 822 nye KOL patienter med oplysninger om smoking habits og anvendt timer ifg. Patienten. Kun 33,2% af disse 434 ptt. Opfyldte alle kriterier.