Dr. Needham is Professor of Pulmonary and Critical Care Medicine, and of Physical Medicine and Rehabilitation at the Johns Hopkins University in Baltimore, USA. He is Director of the “Outcomes After Critical Illness and Surgery” (OACIS) Research Group and core faculty with the Armstrong Institute for Patient Safety and Quality, both at Johns Hopkins. From a clinical perspective, he is an attending physician in the medical intensive care unit at Johns Hopkins Hospital and Medical Director of the Johns Hopkins Critical Care Physical Medicine and Rehabilitation program. Dr. Needham received his MD degree from McMaster University in Hamilton, Canada, and completed both his residency in internal medicine and his fellowship in critical care medicine at the University of Toronto. He obtained his PhD in Clinical Investigation from the Bloomberg School of Public Health at Johns Hopkins University. Notably, prior to his medical training, he completed Bachelor and Master degrees in Accounting and practiced in a large international accounting firm, with a focus in the health care field. Dr. Needham is Principal Investigator on a number of NIH research grants and has authored more than 250 publications. His research interests include evaluating and improving ICU patients’ long-term physical, cognitive and mental health outcomes, including research in the areas of sedation, delirium, early physical rehabilitation, and knowledge translation and quality improvement.

1. 1
The New 2018 SCCM PADIS Guidelines:
Quick Hits of Recommendations for
Sedation, Delirium and Mobility
Dale Needham, MD, PhD
Professor, Pulmonary & Critical Care, and Physical Medicine & Rehab
dale.needham@jhmi.edu
Twitter: @DrDaleNeedham @icurehab #icurehab
www.hopkinsmedicine.org/OACIS

2. Financial Disclosure/Conflict of Interest
• Reck Medical Devices & Baxter Healthcare agreed to lend
bedside cycle ergometers and provide amino acid
product/grant funding, respectively, for a NIH-funded RCT
of early exercise & nutrition in the ICU
• I was a member of SCCM PADIS Guideline committee, and
Chair of the Mobility/Rehab section of PADIS
Disclosure

3. Introduction
4
2018 Pain, Agitation/sedation, Delirium, Immobility, and
Sleep disruption (PADIS) guideline
• Updating 2013 PAD guidelines by:
– Adding 2 new topics: rehab/mobilization & sleep disruption
– Including patients as collaborators and co-authors
– Adding experts from Europe & Australia
• 37 recommendations & 2 ungraded good practice statements
• 2 of 37 recommendations, rated as “strong”
• 32 ungraded statements (non-actionable descriptive questions)

4. Agitation/Sedation
30
2013 Guidelines
• Focus on improving patient short-term outcomes
2018 Guidelines
• Focus on improving post-ICU outcomes, investigating:
– Sedation delivery paradigm & specific sedative medications
• 3 actionable (PICO) question + 3 descriptive questions

5. Light vs. Deep Sedation
32
Evidence: 8 RCTs, 3 observational study

6. Light vs. Deep Sedation (?Harms)
36
• 90 days mortality (2 RCTs, 324 pts)
– Not significant, RR 1.01 (95% CI, 0.80 to 1.27; low quality)
• Self-extubation (4 RCT, 546 pts)
– Not significant, RR 1.29 (95% CI, 0.58 to 2.88; low quality)
• Light sedation was NOT associated with:
– PTSD (2 RCTs, 62 pts), RR 0.67 (95% CI, 0.12 to 3.79)
– Depression (2 RCTs, 128 pt), RR 0.76 (95% CI, 0.10 to 5.58)
– Delirium (2 RCTs, 140 pts), RR 0.96 (95% CI, 0.80 to 1.16)

7. Light vs. Deep Sedation
37
• Tracheostomy rate (1 RCT & 1 observational, 452 pts)
– Reduced, RR 0.57 (95% CI, 0.41 to 0.80)
• Time to extubation (3 RCTs, 453 pts; low quality)
– Associated w/ shorter time, MD -0.77 days (95% CI, -2.04 to 0.50)
• Time to extubation (3 observational, 1524 pts; low quality)
– Associated w/ shorter time, MD -3.46 days (95% CI, -5.70 to -1.23)

8. Recommendation …
43
Recommendation:
We suggest using light vs. deep sedation in critically ill, mech -
ventilated adults (conditional recommendation, low quality of evidence).

9. Choice of Sedative:
Medical & Surgical pts (Non cardiac surgery)
47
Question: For sedation in critically ill, mech ventilated adults…
Should Propofol, as compared to a Benzodiazepine, be used?
Should Dexmed, as compared to a Benzodiazepine, be used?
Should Dexmed, as compared to Propofol, be used?

10. Choice of Sedative:
Medical & Surgical pts (Non cardiac surgery)
49
Propofol vs. Benzodiazepine:
• Time to extubation (10 RCTs, 423 pts)
– Reduced by 11.6 hr (95% CI, -15.6 to -7.6; low quality)
• Time to light sedation (10 RCTs, 357 pts)
– Reduced by 7.2 hr (95% CI, -8.9 to -5.5; low quality)
Dexmed vs. Benzodiazepine (BZD):
• No significant benefit* of Dexmed over BZD infusion for:
– Duration of mechanical ventilation (5 RCT, 1052 pts)
– ICU length of stay (3 RCTs, 969 pts)
– Risk of delirium (4 RCTs, 1007 pts)
* SEDCOM RCT had lowest ROB & significant decrease extubation time (1.9 d)
and delirium (RR 0.71) – influenced grading of recommendation
Dexmed vs. Propofol:
• No significant difference in time to extubation (3 RCTs, 850 pts)

11. Recommendation …
51
Recommendation:
We suggest using either propofol or dexmedetomidine over
benzodiazepine for sedation in critically ill, mechanically
ventilated adults (conditional recommendation, low quality of
evidence).
NOTE in the existing studies for this recommendation:
− Benzodiazepines mostly given as infusion rather than bolus

12. Delirium
60
• ~50% frequency in ICU patients
• 6 actionable (PICO) question + 5 descriptive questions

13. Delirium pharmacological Prevention
68
Question:
Should a pharmacologic agent (versus no use of this agent) be
used to prevent delirium in critically ill adults?
Rationale: 3 RCTs, 1283 pts
Significant reduction in delirium incidence favoring the pharmacologic agent:
• Haloperidol* (457 pts), RR 0.66; 95% CI, 0.45 to 0.97; low quality
− *Update: REDUCE RCT (1789 pts): No effect on delirium or survival
• Risperidone (126 pts), RR 0.35; 95% CI, 0.16 to 0.77; low quality
• Dexmed** (700 pts), OR 0.35; 95% CI, 0.22 to 0.54; low quality
**Su et al Dexmed for prevention of delirium in elderly patients after non-cardiac surgery. Lancet 2016
low severity of illness; only surgical pts, assessing short-term outcomes; cost & side effects

14. Delirium pharmacological Prevention
69
Recommendation:
We suggest NOT using haloperidol, an atypical
antipsychotic, dexmedetomidine, statin, or ketamine to
prevent delirium in all critically ill adults (Conditional
recommendation, very low to low quality of evidence)

15. Haloperidol vs. No Medication (Treatment)
71
• Duration of Delirium (3 RCTs, 265 pts)
– NOT significant, Increased by 0.29 days (95% CI, -1.49 to 2.07)
• Duration of Mechanical Ventilation (2 RCT, 124 pts)
– Not significant, Reduced by 1.12 days (95% CI, -4.85 to 2.61)
• ICU Mortality (3 RCTs, 265 pts)
– NOT significant, RR 1.00 (95% CI, 0.62 to 1.61)

16. Atypical Antipsychotic vs. None (Treatment)
72
• Duration of Delirium (2 RCTs, 102 pts)
– NOT significant, Reduced by 0.87 days (95% CI, -6.70 to 4.97)
• Duration of Mechanical Ventilation (2 RCTs, 95 pts)
– NOT significant, Reduced by 0.34 days (95% CI, -6.54 to 5.86)
• Length of ICU Stay (2 RCTs, 102 pts)
– NOT significant, Increased by 1.93 days (95% CI, -1.17 to 5.68)
• ICU Mortality (2 RCT, 102 pts)
– NOT significant, RR 0.75 (95% CI, 0.29 to 1.96)

17. 73
Rationale, includes:
• Unnecessary continuation causes significant morbidity & cost
Recommendation:
We suggest NOT routinely using haloperidol and atypical
antipsychotic to treat delirium (conditional recommendation, low quality
of evidence).
Antipsychotic/statin vs. None (Treatment)

18. 75
Rationale: 1 RCT (71 pts)
• Significant increase in ventilator-free hours
– Mean Difference 17 hrs (95% CI, 4 to 33 hrs); very low quality
• NO effect on ICU/Hosp LOS or hospital discharge location
Recommendation:
We suggest using dexmedetomidine for delirium in mechanically
ventilated adults where agitation is precluding weaning/extubation
(conditional recommendation, low quality of evidence).
Dexmedetomidine vs. Placebo (Treatment)

19. 82
Rationale: 5 studies (1 RCT*, 4 Before-after), 1318 pts
• Use of these strategies was associated with:
– Reduced delirium significantly, OR=0.59 (95% CI, 0.39 to 0.88)
– Decreased ICU duration of delirium, ICU LOS & Hospital mortality
Recommendation:
We suggest using a multicomponent, non-pharmacologic
intervention that is focused on (but not limited to) reducing
modifiable risk factors for delirium, improving cognition, and
optimizing sleep, mobility, hearing, and vision in critically ill adults
(conditional recommendation, low quality of evidence)
Non-Pharmacological Treatment
Multi-component
*Int J Nurs Stud 2015; 52:1423–1432 (N=123 patients in Korea – no effect on delirium & LOS

20. Why add “Immobility” to PAD
(Rehabilitation/Mobilization)
84
• ICU-Acquired muscle Weakness (ICUAW)
– Present in 25-50% of critically ill patients
– Associated w/ long-term survival, physical function & quality of life
– Immobility/bed rest is an important risk factor
• Mobility/rehab also may be beneficial for delirium
• Assoc. of pain & sedation status/practices w/ ICU Rehab
• 1 actionable (PICO) question + 3 descriptive questions

21. Efficacy and Benefit
96
1. Muscle strength at ICU discharge (6 RCTs, 304 pt)
– Improved by 6.2 points (95% CI, 1.7 to 10.8; scale is 0 to 60)
– low quality (statistical heterogeneity, CI includes MCID)
2. Duration of mech. ventilation (11 RCTs, 1128 pt)
– Reduced by 1.3 days (95% CI, 2.4 to 0.2 days)
– low quality (2 large RCT high ROB, competing risk, heterogeneity)
3. Quality of life (SF-36 Physical function) w/ in 2 mo. (4 RCTs, 303 pt)
– Improved by SMD of 0.64 (95% CI, -0.05 to 1.34 – not significant)
4. Hospital mortality (13 RCTs, 1421 pt)
– No effect, RR=0.93 (95% CI, 0.74 to 1.18) – moderate quality (CI includes harm)
5. Physical func: small N d/t heterogeneity in measures; NOT significant
– Timed Up & Go test, mean dif 2.22 (95% CI, -4.99 to 9.43; 3 RCT, 172 pt)
– Phys Func. in ICU (PFIT) test, mean dif -0.19 (95% CI, -0.69 to 0.31; 3 RCT, 209 pt)

22. Recommendation …
99
Formal Recommendation:
We suggest performing rehabilitation or mobilization in critically
ill adults (conditional recommendation, low quality evidence).
• Implementation influenced by feasibility, staffing &
resources across ICUs

23. Safety and Risk
102
Question:
… is receiving rehab/mobilization (performed either in-bed or out-of-bed)
commonly associated with patient-related safety events or harm?
Ungraded Statement:
Serious safety events or harms do not occur commonly during
physical rehabilitation or mobilization.
• Rationale: 10 observational & 9 RCTs
– Serious safety events/harms were rare (15 during >12,200 sessions)
– Majority were respiratory-related (4 desaturation & 3 unplanned extubation)

24. Table 1. Safety criteria for start/stop rehab/mobilization (in-bed or out-of-bed)
105
Safety criteria Starting a Rehab/Mobility session Stopping a Rehab/Mobility session
System Start when ALL of the following are present: Stop when ANY of the following are present:
Cardiovascular ● Heart rate between 60 - 130 bpm
● Systolic B/P between 90 - 180 mmHg, or
● Mean arterial pressure between 60-100
● Heart rate decreases <60 or increases >130
● Systolic decreases <90 or increases >180
● MAP decreases <60 or increases >100
Respiratory ● Respiratory rate between 5 - 40 bpm
● SpO2 >=88%
● FiO2 <0.6 & PEEP <10 cmH2O
● Airway (ETT or trach) adequately secured
● Resp. rate decreases <5 or increases >40
● SpO2 decreases <88%
● Concerns re: securement of ETT or trach
Neurologic ● Able to open eyes to voice ● Change in LOC
Other The following should be absent:
● New or symptomatic arrhythmia
● Chest pain with concern for ischemia
● Unstable spinal injury or lesion
● Unstable fracture
● Active or uncontrolled GI bleed
Mobility may be performed with
● Femoral VAD, except sheath, in which hip
mobilization is generally avoided
● Continuous renal replacement therapy
● Vasoactive medication infusion
If following develop & clinically relevant:
● New/symptomatic arrhythmia
● Chest pain with concern for ischemia
● Ventilator asynchrony
● Fall
● Bleeding
● Medical device removal or malfunction
● Distress reported by patient or clinician
“… not be a substitute for clinical judgment”
“All thresholds should be interpreted or modified,
as needed, in the context of individual patients’
clinical symptoms, expected values, recent trends, and
any clinician-prescribed goals or targets.”

25. Publications related to the 2018 SCCM PADIS guidelines:
• PADIS Guidelines
• Executive Summary
• Interpreting & Implementing 2018 PADIS Guideline
• Methodologic Innovation in 2018 PADIS Guideline
Free access to publications & PADIS presentation:
http://www.sccm.org/ICULiberation/Guidelines
2018 SCCM

26. 1John Devlin, PharmD (Chair for Overall CPG)
2Yoanna Skrobik, MD, MSc (Vice-Chair)
3Céline Gélinas, RN, PhD (Chair, Pain)
4Aaron Joffe, DO
5Kathleen Puntillo RN, PhD
6Gerald Chanques, MD, PhD
7Jean-Francois Payen, MD, PhD
8Paul Szumita, PharmD
9Pratik Pandharipande, MD, MSCI(Chair, Sedation)
10Richard Riker, MD
11Michele Balas, RN, PhD
12Yahya Shehabi, MD, PhD
13John Kress, MD
14Bryce Robinson MD, MS
15Arjen Slooter, MD, PhD (Chair, Delirium)
16Brenda Pun, RN, DNP
17Gilles Fraser, PharmD, MCCM
18Margaret Pisani, MD, MPH
19Karin Neufeld, MD, MPH
20Mark van den Boogaard, RN, PhD
21Dale Needham, MD, PhD (Chair, Immobility)
22Linda Denehy, PT, PhD
23Michelle Kho, PT, PhD
24Chris Winkelman, RN, PhD
25Nathaniel Brummel, MD, MSCI
26Jocelyn Harris, OT, PhD
27Julie Lanphere, DO
28Sina Nikayin, MD (research staff)
29Paula Watson, MD, MPH (Chair, Sleep)
30Xavier Drouot, MD, PhD
31Gerald Weinhouse, MD
32Karen Bosma, MD
33Sharon McKinley, RN, PhD
34Waleed Alhazzani, MD, MSc (Chair, Methods)
35Mark Nunnally, MD
36Bram Rochwerg, MD, MSc
37John Centofani, MD, MSc
38Carrie Price, MLS (medical librarian)
39Cheryl Misak, PhD (patient rep)
40Ken Kiedrowski, MA (patient rep) 108
Co-authors for entire Guideline