Immobility 2018 SCCM Clinical Practice Guidelines for the

Immobility 2018 SCCM Clinical Practice Guidelines for the

Immobility 2018 SCCM Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU Introduction 2018 pain, agitation/sedation, delirium, immobility, and sleep disruption (PADIS) guidelines Update of 2013 PAD guidelines by: Adding 2 new topics: rehabilitation/mobilization and sleep disruption Including patients as collaborators and coauthors Adding experts from Europe and Australia 37 recommendations and two ungraded good practice statements Only 2 of 37 recommendations rated as strong 32 ungraded statements (nonactionable descriptive questions) Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Methods Grading of Recommendations Assessment, Development, and Evaluation

(GRADE) methodology Chairs, section heads, panel members, ICU survivors, librarian Topics selected and prioritized, PICO questions finalized, and then: Literature review: 5 electronic databases, 1990 to October 2015 Evaluation of study (primarily RCT) methodologic rigor: risk of bias Formulation of preliminary recommendations: GRADE evidence-todecision process In-person discussion among full panel (SCCM 2017 Congress) Anonymous recommendation voting > 80% agreement with > 70% response rate 100% of the panel voted (with reminders and prompts) ICU survivors participated in every step Devlin JW, et al. PADIS Method Innovations Paper. Crit Care Med 2018; 46:1457-1463 Society of Critical Care Medicine. All rights reserved. Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Formulate Select question outcomes Rate importance Systematic

review Evidence profile 1 Pooled estimate of effect per outcome 2 Quality of evidence per outcome High Moderate |Low Low| Very low High| Moderate Very low Critical Outcome2 Critical Outcome3 Important Outcome4 Not imp ort start high low

1. 2. 3. 4. 5. 1. Large effect 2. Dose response 3. Antagonistic bias an t Exclude RCT observational rate up Outcome1 rate down Patient, intervention, comparison, outcome (PICO) question Risk of bias Inconsistency Indirectness

Imprecision Publication bias systematic review of evidence Evidence-to-Decision (EtoD) framework: Balance benefits/downsides Quality of evidence Values and preferences Resource use (cost) Feasibility Acceptability Formulate preliminary recommendation For or against an action Strong or conditional (strength) Society of Critical Care Medicine. Slide courtesy of Waleed Alhazzani, MD, MSc All rights reserved. Section Panel Members Large group discussion Rate overall quality of evidence across outcomes Electronic voting (blinded to

others voting) Final recommendation Strong Versus Conditional Recommendations Patients Strong Conditional Applies to almost all patients Applies to most patients (significant exceptions based on patient condition, values, and preferences) Supporting evidence Moderate- to high-quality across broad populations Conflicting, low quality, insufficient, and/or limited populations Benefits versus burdens Benefits clearly outweigh burdens May be close balance between benefits and burdens Influence of future research Limited potential to change recommendation

Possible/probable potential to change recommendation Performance or quality indicators Can be readily adapted in most healthcare systems Requires significant deliberation at the local level based on practice patterns, patients served, and resource availability Balas MC, Weinhouse GL, Denehy L, et al. Interpreting and implementing the 2018 pain, agitation/sedation, delirium, immobility, and sleep disruption clinical practice guidelines. Crit Care Med. 2018 Sep;46(9):1464-1470. Society of Critical Care Medicine. All rights reserved. PICO and Descriptive Questions for PADIS Clinical Practice Guideline Pain Agitation/Sedation Delirium Factors that influence pain Light vs. deep sedation Delirium prediction Assessment

Patient self-report Behavioral Proxy reporters Physiologic measures Prevalence, rationale, and outcomes of physical restraint use Risk factors Influence of level of arousal on delirium assessment Outcomes of delirium Protocol-based assessment and management: Analgesia first Analgosedation Daily sedation interruption vs. nurse-protocolized sedation Multimodal analgesia to reduce opioid use: Acetaminophen Nefopam Ketamine Neuropathic analgesia IV lidocaine NSAID Immobility (Rehab/Mobilization)

Sleep Disruption Rehab/mobilization (performed in or out of bed) vs. different rehab/mobilization intervention, placebo, or sham Comparison of sleep in critically ill adults vs.: Healthy adults Delirium (vs. no delirium) MV (vs. no MV) Prevalence of unusual sleep Delirium assessment using valid tool (vs. no assessment) Harm associated with rehab/ mobilization (either in or out of bed) Physiologic/nonphysiologic sleep monitoring Mechanically ventilated patients after cardiac surgery: Propofol vs. benzodiazepines Pharmacologic prevention: Haloperidol Atypical antipsychotic

Statin Dexmedetomidine Ketamine Clinical indicators to safely initiate rehab/mobilization (either in or our of bed) Risk factors affecting ICU sleep quality: Before critical illness ICU-acquired Disrupted sleep outcomes: During ICU admission After ICU discharge Procedural analgesia: Opioid vs. none High- vs. low-dose opioid Local analgesia Nitrous oxide Isoflurane NSAID (systemic/gel) Mechanically ventilated critically ill adults: Propofol vs. benzodiazepines Dexmedetomidine vs. benzodiazepines Propofol vs. dexmedetomidine Pharmacologic treatment: Haloperidol Atypical antipsychotic

Statin Dexmedetomidine Ketamine Clinical indicators to stop rehab/mobilization (either in or out of bed) Pharmacologic sleep improvement: Melatonin Dexmedetomidine Propofol Nonpharmacologic analgesic strategies: Cybertherapy/hypnosis Massage Music Cold therapy Relaxation techniques Objective sedation monitoring tools Nonpharmacologic delirium reduction interventions: Single component: Bright light therapy Multicomponent: ABCDEF bundle 6 Society of Critical Care Medicine.

All rights reserved. Nonpharmacologic sleep improvement: AV vs. PS mode Adaptive vs. PS mode Aromatherapy Music Noise and light reduction Multimodal protocol Why Add Immobility to PAD (Rehabilitation/Mobilization) ICU-acquired muscle weakness (ICUAW) Present in 25%-50% of critically ill patients Associated with long-term survival, physical function, and quality of life Immobility/bed rest is an important risk factor Rehab/mobilization also may be beneficial for delirium Association of pain and sedation status/practices with ICU rehab 1 actionable (PICO) question plus 3 descriptive questions Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Assessing Efficacy of Intervention PICO Question P Critically ill adults I

Rehab/mobilization (performed in bed or out of bed) C Usual care, different rehab/mobilization intervention, placebo, sham O Patient, family, or health system outcomes Society of Critical Care Medicine. All rights reserved. Specific Outcomes Critical outcomes able to be evaluated: Muscle strength at ICU discharge Duration of mechanical ventilation Quality of life Hospital mortality

Physical function Critical outcomes not able to be evaluated because of inadequate data: Cognitive function Mental health Return to work/economic status Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Synthesis of RCT Evidence Substantial heterogeneity* across the PICO question: ICU patient populations (P) Types and timings of rehab/mobilization interventions (I) Comparators for the intervention (C): Usual care rehab/mobilization Same intervention with reduced duration/frequency Later start of the intervention Outcomes and related measures (O) *Affects consistency aspect of GRADE for quality of evidence assessment and limits the inferences/recommendations that can be made.

Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Efficacy and Benefit 1. Muscle strength at ICU discharge (6 RCTs, 304 patients) Improved by 6.2 points (95% CI, 1.7 to 10.8; scale is 0 to 60) Low quality (statistical heterogeneity, CI includes MCID) Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Efficacy and Benefit 2. Duration of mechanical ventilation (11 RCTs, 1,128 patients) Reduced by 1.3 days (95% CI, 2.4 to 0.2 days) Low quality (2 large RCTs, high ROB, competing risk, heterogeneity) Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Efficacy and Benefit 3.

Quality of life (SF-36 physical function) within 2 months (4 RCTs, 303 patients) Improved by SMD of 0.64 (95% CI, 0.05 to 1.34), not significant Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Efficacy and Benefit 4. Hospital mortality (13 RCTs, 1,421 patients) No effect, RR = 0.93 (95% CI, 0.74 to 1.18), moderate quality (CI includes harm) Slide development by: R. Nikooie, MD, J. Devlin, PharmD, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Efficacy and Benefit 5. Physical function: small N due to heterogeneity in measures, not significant Timed Up and Go (TUG) Test, MD 2.22 (95% CI, 4.99 to 9.43, 3 RCTs, 172 patients) Physical Function in ICU Test (PFIT), MD 0.19 (95% CI, 0.69 to 0.31, 3 RCTs, 209 patients) Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD

Society of Critical Care Medicine. All rights reserved. Evidence-to-Decision (EtoD) Summary Rehabilitation/mobilization assessed as: Feasible Acceptable to key stakeholders Likely to be cost-effective (based on preliminary data) Indirect evidence plus discussion of panel (including ICU patient): Patients probably value the benefits of rehab/mobilization Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Recommendation Given a small benefit and the low overall quality of evidence, panel members agreed that: Desirable consequences probably outweigh undesirable consequences. Formal Recommendation: We suggest performing rehabilitation or mobilization in critically ill adults (conditional recommendation, low quality evidence). Supports performing rehab/mobilization over usual care or similar interventions with a reduced duration, frequency, or later onset Implementation influenced by feasibility, staffing, and resources across ICUs Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved.

Safety and Risk Descriptive 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 rehab/mobilization. Rationale: 10 observational studies and 9 RCTs Serious safety events/harms were rare (15 during > 12,200 sessions). Most were respiratory-related (4 desaturation and 3 unplanned extubation). Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Indicators for Initiation Descriptive Question: What aspects of patient clinical status are indicators for the safe initiation of rehab/mobilization (performed either in bed or out of bed)? Ungraded Statement: Major indicators for safely initiating rehab/mobilization include stability in cardiovascular, respiratory, and neurologic status. Vasoactive infusion and mechanical ventilation are not barriers to initiation if patient is otherwise stable with use of these therapies (17 studies, 2,774 patients). Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved.

Indicators for Stopping Descriptive Question: Which aspects of patient clinical status are indicators for stopping rehab/mobilization (performed either in bed or out of bed)? Ungraded Statement: Major indicators for stopping rehab/mobilization include new cardiovascular, respiratory, or neurologic instability. Other events (eg, fall, medical device removal/malfunction, patient distress) are also indications for stopping (14 studies, 2,617 patients). Society of Critical Care Medicine. All rights reserved. Table 1. Safety Criteria for Start/Stop Rehab/Mobilization (in Bed or out of Bed) Safety Criteria Starting a Rehab/Mobilization Session Stopping a Rehab/Mobilization Session System Start when all of the following are present: Stop when any of the following are present: Cardiovascular Heart rate 60-130 beats/min, Systolic BP 90-180 mm Hg, or MAP 60-100 mm Hg

Heart rate decreases < 60 or increases > 130 beats/min Systolic BP decreases < 90 or increases > 180 mm Hg MAP decreases < 60 or increases > 100 mm Hg Respiratory . not be a substitute for clinical rate. 5-40 breaths/min Respiratoryjudgment rate decreases < 5 or increases > 40 breaths/min Respiratory . SpO2 88% SpO2 decreases < 88% Concerns about securing ETT or tracheostomy tube FIO2 < 0.6 and PEEP < 10 cm H2O Airway (ETT or tracheostomy tube) All thresholds should beadequately interpreted or modified, as needed, in secured Neurologic Other the context of individual patients clinical symptoms, expected Change in level of consciousness values, recent trends, and any clinician-prescribed goals or targets. Able to open eyes to voice

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 bleeding Mobility may be performed with Femoral ventricular assist device, except sheath, in which hip mobilization is generally avoided Continuous renal replacement therapy Vasoactive medication infusion Society of Critical Care Medicine. All rights reserved. If following develop and are clinically relevant: New or symptomatic arrhythmia Chest pain with concern for ischemia Ventilator asynchrony Fall Bleeding Medical device removal or malfunction Distress reported by patient or clinician Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Evidence Gaps Directions for future research: Understanding difference in outcomes by: o Type, timing, frequency, duration, and intensity of intervention Expertise/training of personnel delivering interventions Influence of patient condition (eg, pre-ICU functional status, delirium and sedation, muscle weakness) on outcomes after rehab/ mobilization

Methods to assess patient experience during rehab/mobilization Standard data: intervention, safety, and short- and long-term outcomes Measurement properties of short- and long-term outcome measures Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. PADIS Guideline Authors 1 2 John W. Devlin, PharmD (Chair for Overall CPG) Yoanna Skrobik, MD, MSc (Vice-Chair) Dale M. Needham, MD, PhD (Chair, Immobility) Linda Denehy, PT, PhD 23 Michelle E. Kho, PT, PhD 24 Chris Winkelman, RN, PhD 25 Nathaniel E. Brummel, MD, MSCI 26 Jocelyn Harris, OT, PhD 27 Julie Lanphere, DO 28 Sina Nikayin, MD (research staff) 21 Cline Glinas, RN, PhD (Chair, Pain) 4 Aaron M. Joffe, DO 5

Kathleen A. Puntillo RN, PhD 6 Gerald Chanques, MD, PhD 7 Jean-Francois Payen, MD, PhD 8 Paul M. Szumita, PharmD 3 Pratik P. Pandharipande, MD, MSCI(Chair, Sedation) Richard R. Riker, MD 11 Michele C. Balas, RN, PhD 12 Yahya Shehabi, MD, PhD 13 John P. Kress, MD 14 Bryce R.H. Robinson MD, MS 22 9 10 Arjen Slooter, MD, PhD (Chair, Delirium) Brenda T. Pun, RN, DNP 17 Gilles L. Fraser, PharmD, MCCM 18 Margaret Pisani, MD, MPH 19 Karin J. Neufeld, MD, MPH 20

Mark van den Boogaard, RN, PhD Paula L. Watson, MD, MPH (Co-Chair, Sleep) Gerald L. Weinhouse, MD (Co-Chair, Sleep) 31 Xavier Drouot, MD, PhD 32 Karen Bosma, MD 33 Sharon McKinley, RN, PhD 29 30 Waleed Alhazzani, MD, MSc (Chair, Methods) Mark E. Nunnally, MD 36 Bram Rochwerg, MD, MSc 37 John E. Centofanti, MD, MSc 15 34 16 35 Carrie Price, MLS (medical librarian) Cheryl J. Misak, PhD (patient rep) 40 Ken Kiedrowski, MA (patient rep) 41 Pamela Flood, MD (patient rep) 38

39 Slide development by: R. Nikooie, MD, C. Chessare, MS, D. Needham, MD, PhD Society of Critical Care Medicine. All rights reserved. Acknowledgement Slide content has been provided by the PADIS Guideline Leadership. 24 Society of Critical Care Medicine. All rights reserved. For more information on how to implement the 2018 PADIS guidelines, please visit the ICU Liberation Campaign website: http://www.sccm.org/ICULiberation Society of Critical Care Medicine. All rights reserved.

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