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The New 2018 SCCM PADIS Guidelines:
Quick Hits of Recommendations for
Sedation, Delirium and Mobility
Dale Needham, MD, ...
Financial Disclosure/Conflict of Interest
• Reck Medical Devices & Baxter Healthcare agreed to lend
bedside cycle ergomete...
Introduction
4
2018 Pain, Agitation/sedation, Delirium, Immobility, and
Sleep disruption (PADIS) guideline
• Updating 2013...
Agitation/Sedation
30
2013 Guidelines
• Focus on improving patient short-term outcomes
2018 Guidelines
• Focus on improvin...
Light vs. Deep Sedation
32
Evidence: 8 RCTs, 3 observational study
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...
Light vs. Deep Sedation
37
• Tracheostomy rate (1 RCT & 1 observational, 452 pts)
– Reduced, RR 0.57 (95% CI, 0.41 to 0.80...
Recommendation …
43
Recommendation:
We suggest using light vs. deep sedation in critically ill, mech -
ventilated adults (...
Choice of Sedative:
Medical & Surgical pts (Non cardiac surgery)
47
Question: For sedation in critically ill, mech ventila...
Choice of Sedative:
Medical & Surgical pts (Non cardiac surgery)
49
Propofol vs. Benzodiazepine:
• Time to extubation (10 ...
Recommendation …
51
Recommendation:
We suggest using either propofol or dexmedetomidine over
benzodiazepine for sedation i...
Delirium
60
• ~50% frequency in ICU patients
• 6 actionable (PICO) question + 5 descriptive questions
Delirium pharmacological Prevention
68
Question:
Should a pharmacologic agent (versus no use of this agent) be
used to pre...
Delirium pharmacological Prevention
69
Recommendation:
We suggest NOT using haloperidol, an atypical
antipsychotic, dexmed...
Haloperidol vs. No Medication (Treatment)
71
• Duration of Delirium (3 RCTs, 265 pts)
– NOT significant, Increased by 0.29...
Atypical Antipsychotic vs. None (Treatment)
72
• Duration of Delirium (2 RCTs, 102 pts)
– NOT significant, Reduced by 0.87...
73
Rationale, includes:
• Unnecessary continuation causes significant morbidity & cost
Recommendation:
We suggest NOT rout...
75
Rationale: 1 RCT (71 pts)
• Significant increase in ventilator-free hours
– Mean Difference 17 hrs (95% CI, 4 to 33 hrs...
82
Rationale: 5 studies (1 RCT*, 4 Before-after), 1318 pts
• Use of these strategies was associated with:
– Reduced deliri...
Why add “Immobility” to PAD
(Rehabilitation/Mobilization)
84
• ICU-Acquired muscle Weakness (ICUAW)
– Present in 25-50% of...
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...
Recommendation …
99
Formal Recommendation:
We suggest performing rehabilitation or mobilization in critically
ill adults (...
Safety and Risk
102
Question:
… is receiving rehab/mobilization (performed either in-bed or out-of-bed)
commonly associate...
Table 1. Safety criteria for start/stop rehab/mobilization (in-bed or out-of-bed)
105
Safety criteria Starting a Rehab/Mob...
Publications related to the 2018 SCCM PADIS guidelines:
• PADIS Guidelines
• Executive Summary
• Interpreting & Implementi...
1John Devlin, PharmD (Chair for Overall CPG)
2Yoanna Skrobik, MD, MSc (Vice-Chair)
3Céline Gélinas, RN, PhD (Chair, Pain)
...
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The New 2018 SCCM PADIS Guidelines: Quick Hits of Recommendations for Sedation, Delirium and Mobility - Dale Needham

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.

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The New 2018 SCCM PADIS Guidelines: Quick Hits of Recommendations for Sedation, Delirium and Mobility - Dale Needham

  1. 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. 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. 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. 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. 5. Light vs. Deep Sedation 32 Evidence: 8 RCTs, 3 observational study
  6. 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. 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. 8. Recommendation … 43 Recommendation: We suggest using light vs. deep sedation in critically ill, mech - ventilated adults (conditional recommendation, low quality of evidence).
  9. 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. 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. 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. 12. Delirium 60 • ~50% frequency in ICU patients • 6 actionable (PICO) question + 5 descriptive questions
  13. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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

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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.

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