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Learning Objectives

Learning Objectives. Manage adult patients who need sedation and analgesia while receiving ventilator support according to current standards and guidelines Use validated scales for sedation, pain, agitation and delirium in the management of these critically ill patients

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Learning Objectives

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  1. Learning Objectives • Manage adult patients who need sedation and analgesia while receiving ventilator support according to current standards and guidelines • Use validated scales for sedation, pain, agitation and delirium in the management of these critically ill patients • Assess recent clinical findings in pain, agitation, and delirium management and incorporate them into the management of ICU patients

  2. Reflect On Your Current Practice • Are you familiar with the new PAD guidelines? • Have you incorporated them into your practice? • Are you targeting a light level of sedation? • Do you use the ABCDE bundle or a similar structure at your institution? • What are the barriers to changing your practice? • What are the barriers to changing your system?

  3. Need for Sedation and Analgesia Prevent pain and anxiety Decrease oxygen consumption Decrease the stress response Patient-ventilator synchrony Avoid adverse neurocognitive sequelae Depression PTSD Delirium Anxiety Avoid post-intensive care syndrome Rotondi AJ, et al. Crit Care Med. 2002;30:746-752. Weinert C. Curr Opin in Crit Care. 2005;11:376-380. Kress JP, et al. Am J Respir Crit Care Med. 1996;153:1012-1018.

  4. A Word About the 2013 PAD Guidelines • Supporting organizations • American College of Critical Care Medicine (ACCM) • Society of Critical Care Medicine (SCCM) • American Society of Health-System Pharmacists (ASHP) • Some of this presentation is based on the guidelines • Guideline recommendations are evidence-based and will not apply to all patients • Intended as a roadmap for developing integrated, evidence-based, and patient-centered protocols

  5. Barr J, et al. Crit Care Med. 2013;41:263-306.

  6. What’s Different about this Version of the PAD Guidelines? Methods • GRADE measures quality and strength • Quality of Evidence: • Evaluation of the available data • High orlowquality? • A (high), B (moderate), C (low) • Strength of Recommendation: • Confidence that following the recommendation will cause more good than harm (1 or 2) • Strong “We Recommend” • Weak “We Suggest” • Grading of Recommendations Assessment, Development and Evaluation method • http://www.gradeworkinggroup.org. Accessed March 2013.

  7. What’s Different About this Version ofthe PAD Guidelines? Results Psychometric assessments comparing pain, sedation and delirium monitoring tools More patient-centered, integrated and interdisciplinary approach to managing pain, agitation, and delirium Far less emphasis on specific across-the-board pharmacologic recommendations Greater emphasis on the pathophysiology, risks and management of delirium Barr J, et al. Crit Care Med. 2013;41:263-306.

  8. What’s Different About this Version ofthe PAD Guidelines? Scope Far larger than the 2002 guidelines! 2002 28 recommendations 2008 36 recommendations (Surviving Sepsis Guidelines) 2013 53 recommendations and statements Not meant to be comprehensive Expect Variability Less Prescriptive More Proscriptive Strategies rather than agents Result = a lot of flexibility Pros Cons Expect variation (that is still compliant) Barr J, et al. Crit Care Med. 2013;41:263-306.

  9. What’s Different About this Version ofthe PAD Guidelines? Scope Far larger than the 2002 guidelines! 53 recommendations and statements vs 28 recommendations in 2002 vs 36 recommendations in the 2008 Surviving Sepsis Guidelines Not meant to be comprehensive: Addresses only questions of greatest importance to ICU clinicians Some questions have no recommendations due to lack of research Identifies areas for future research Barr J, et al. Crit Care Med. 2013;41:263-306.

  10. PAD Statements vs Recommendations Barr J, et al. CritCare Med. 2013;41:263-306.

  11. Pain, Agitation, and Delirium Are Interrelated Pain Agitation Delirium Barr J, et al. CritCare Med. 2013;41:263-306.

  12. PAD Care Bundle ASSESS TREAT PREVENT Barr J, et al. Crit Care Med. 2013;41:263-306.

  13. Pain, Agitation, and Delirium Are Interrelated Pain Agitation Delirium Barr J, et al. CritCare Med. 2013;41:263-306.

  14. PAD Pain AssessmentRecommendations • We recommend that pain be routinely monitored in all adult ICU patients (+1B) • The BPS and the CPOT are the most valid and reliable behavioral pain scales for monitoring pain in adult ICU patients who are unable to self-report and in whom motor function is intact and behaviors are observable (B) • We do not suggest that vital signs be used alone for pain assessment in adult ICU patients (–2C) • We suggest that vital signs may be used as a cue to begin further assessment of pain (+2C) Barr J, et al. CritCare Med. 2013;41:263-306.

  15. Assessing Pain • For patients able to self-report • Numeric Rating Scale • “On a scale of 0 to 10, how do you rate your current level of pain?” • For patients unableto self-report • Behavioral Pain Scale (BPS) • Critical Care Pain Observation Tool (CPOT) • Barr J, et al. Crit Care Med. 2013;41:263-306. • Payen JF, et al. Crit Care Med. 2001;29(12):2258-2263. • Gélinas C, et al. Am J Crit Care. 2006;15:420-427.

  16. Behavioral Pain Scale (BPS) 3-12 Payen JF, et al. Crit Care Med. 2001;29:2258-2263.

  17. Critical Care Pain Observation Tool Gélinas C, et al. Am J Crit Care. 2006;15:420-427.

  18. Assessing Pain Reduces Sedative/Hypnotic Use What proportion of MV ICU patients received sedative or hypnotic medication? Payen JF, et al. Anesthesiology. 2009;111:1308-1316.

  19. Assessing Pain Associated With Improved Outcomes Payen JF, et al. Anesthesiology. 2009;111:1308-1316.

  20. PAD Pain Management Recommendations • Preemptively treat chest tube removal with either analgesics and/or nonpharmacologic therapy (1C) • Suggest preemptively treating other types of procedural pain with analgesic and/or nonpharmacologic therapy (2C) • Use opioids as first-line therapy for treatment of non-neuropathic pain (1C) • Suggest using non-opioid analgesics in conjunction with opioids to reduce opioid requirements and opioid related side effects (2C) • Use gabapentin or carbamazepine, in addition to intravenous opioids, for treatment of neuropathic pain (1A) • Use thoracic epidural for postoperative analgesia in abdominal surgery patients (1B) • Suggest thoracic epidural analgesia be used for patients with traumatic rib fractures (2B) Barr J, et al. Crit Care Med. 2013;41:263-306.

  21. Pain, Agitation, and Delirium Are Interrelated Pain Agitation Delirium Barr J, et al. CritCare Med. 2013;41:263-306.

  22. PAD Agitation/SedationAssessmentRecommendations • Depth and quality of sedation should be routinely assessed in all ICU patients (1B) • The RASS and SASS are the most valid and reliable scales for assessing quality and depth of sedation in ICU patients (B) • Suggest using objective measures of brain function to adjunctively monitor sedation in patients receiving neuromuscular blocking agents (2B) • Use EEG monitoring either to monitor non-convulsive seizure activity in ICU patients at risk for seizures, or to titrate electrosuppressive medication to achieve burst suppression in ICU patients with elevated intracranial pressure (1A) Barr J, et al. Crit Care Med. 2013;41:263-306.

  23. Sedation-Agitation Scale (SAS) Riker RR, et al. Crit Care Med. 1999;27:1325-1329. Brandl K, et al. Pharmacotherapy. 2001;21:431-436.

  24. Richmond Agitation Sedation Scale (RASS) Sessler CN, et al. Am J Respir Crit Care Med. 2002;166(10):1338-1344.

  25. PAD Depth of Sedation Statements • Maintaining light levels of sedation in adult ICU patients is associated with improved clinical outcomes (eg, shorter duration of mechanical ventilation and a shorter ICU length of stay [LOS]) (B) • Maintaining light levels of sedation increases the physiologic stress response, but is not associated with an increased incidence of myocardial ischemia (B) • The association between depth of sedation and psychological stress in these patients remains unclear (C) Barr J, et al. CritCare Med. 2013;41:263-306.

  26. PAD Depth of Sedation Recommendations • We recommend that sedative medications be titrated to maintain a light rather than a deep level of sedation in adult ICU patients, unless clinically contraindicated (+1B) • We recommend either daily sedation interruption or a light target level of sedation be routinely used in mechanically ventilated adult ICU patients (+1B) Barr J, et al. CritCare Med. 2013;41:263-306.

  27. Early Deep Sedation Longer MV and Reduced 6 Month-Survival Survival Fraction Intubated ShehabiY, et al. Am J Respir Crit Care Med. 2012;186(8):724-731.

  28. Mental Health After Light or Deep Sedation • Patients: adults requiring mechanical ventilation • Sedation with midazolam • Light: Ramsay 1-2, intermittent injection • Deep: Ramsay 3-4, continuous infusion • Results • Primary endpoints (4 weeks after ICU discharge) • Trend towards more PTSD symptoms with deep sedation • No difference in anxiety or depression scores • Other endpoints: light sedation patients averaged • 1 day shorter on MV (P = 0.03) • 1.5 days shorter LOS (P = 0.03) Treggiari MM, et al. Crit Care Med. 2009;37(9):2527-2534.

  29. Daily Sedation Interruption Decreases Duration of Mechanical Ventilation Hold sedation infusion until patient awake and then restart at 50% of the prior dose “Awake” defined as any 3 of the following: Open eyes in response to voice Use eyes to follow investigator on request Squeeze hand on request Stick out tongue on request • Fewer diagnostic tests to assess changes in mental status • No increase in rate of agitated-related complications or • episodes of patient-initiated device removal • No increase in PTSD or cardiac ischemia Kress JP, et al. N Engl J Med. 2000;342:1471-1477. Needham DM, et al. Crit Care Med. 2012;40(2):502-509

  30. To determine the efficacy and safety of a protocol linking: spontaneous awakening trials (SATs) & spontaneous breathing trials (SBTs) ABC Trial Girard TD, et al. Lancet. 2008;371:126-134.

  31. ABC Trial: Main Outcomes Outcome* SBT SAT+SBT P-value 12 15 0.02 Ventilator-free days Time-to-Event, days Successful extubation, days 7.0 5 0.05 ICU discharge, days 13 9 0.02 Hospital discharge, days 19 15 0.04 Death at 1 year, n (%) 97 (58%) 74 (44%) 0.01 Days of brain dysfunction Coma 3.0 2.0 0.002 Delirium 2.0 2.0 0.50 *Median, except as noted Girard TD, et al. Lancet. 2008;371:126-134.

  32. ABC Trial: 1 Year Mortality Girard TD, et al. Lancet. 2008;371:126-134.

  33. SAT Protocol

  34. SBT Protocol

  35. Protocol + SAT/SBT versus Protocol + SBT Alone Mehta S, et al. JAMA. 2012;308(19):1985-1992.

  36. Nursing-Implemented Sedation Protocol: Barnes Jewish Pilot United States P< 0.001 P= 0.13 P= 0.003 Single center, prospective, trial of 332 consecutive ICU patients requiring mechanical ventilation randomized to protocolized sedation (n = 162) or routine care (n = 159) at Barnes Jewish Hospital from 8/97 to 7/98. Protocol used goal orientated sedation to target Ramsey with bolus requirements before initiation of continuous infusion and uptitration of opioids and benzodiazepines. Brook AD, et al. Crit Care Med. 1999;27(12):2609-2615.

  37. Nursing-Implemented Sedation Protocol: Bocage University Hospital France P= 0.003 P= 0.004 P= 0.001 Single center, prospective, before-after trial of 423 ICU patients requiring mechanical ventilation for > 48 hours before (n = 226) and after (n = 197) implementation of sedation protocol at Bocage University Hospital from 5/99 to 12/03. Protocol used goal orientated sedation to target Q3hr Cambridge scale with bolus requirements before initiation of continuous infusion and uptitration of midazolam Quenot JP, et al. Crit Care Med. 2007;35(9):2031-2036.

  38. Pharmacist Enforced Adherence to an ICU Sedation Guideline: Boston Medical Center MICU P= 0.001 P= 0.002 P= 0.0004 Single center trial of 156 adult MICU patients requiring mechanical ventilation before (n = 78) and after (n = 78) implementation of RPh enforced guideline sedation management at Boston Medical Center. Guideline addressed use of agent selection, goal oriented therapy, and dose limitation strategies. Marshall J, et al. Crit Care Med. 2008;36(2):427-433.

  39. PAD Choice of SedativeRecommendations • We suggest that analgesia-first sedation be used in mechanically ventilated adult ICU patients (+2B) • We suggest that sedation strategies using nonbenzodiazepine sedatives (either propofol or dexmedetomidine) may be preferred over sedation with benzodiazepines (either midazolam or lorazepam) to improve clinical outcomes in mechanically ventilated adult ICU patients (+2B) • We suggest that in adult ICU patients with delirium unrelated to alcohol or benzodiazepine withdrawal, continuous IV infusions of dexmedetomidine rather than benzodiazepine infusions be administered for sedation to reduce the duration of delirium in these patients (+2B) Barr J, et al. CritCare Med. 2013;41:263-306.

  40. Analgosedation Analgesic first (A-1), supplement with sedative Acknowledges that discomfort may cause agitation Remifentanil-based regimen Reduces propofol use Reduces median MV time Improves sedation-agitation scores Not appropriate for drug or alcohol withdrawal Park G, et al. Br J Anaesth. 2007;98:76-82. Rozendaal FW, et al. Intensive Care Med. 2009;35:291-298.

  41. Analgosedation • 140 critically ill adult patients undergoing mechanical ventilation in single center • Randomized, open-label trial • Both groups received bolus morphine (2.5 or 5 mg) • Group 1: No sedation (n = 70 patients) - morphine prn • Group 2: Sedation (20 mg/mL propofol for 48 h, 1 mg/mL midazolam thereafter) with daily interruption until awake (n = 70, control group) • Endpoints • Primary • Number of days without mechanical ventilation in a 28-day period • Other • Length of stay in ICU (admission to 28 days) • Length of stay in hospital (admission to 90 days) Strøm T, et al. Lancet. 2010;375:475-480.

  42. AnalgosedationResults • Patients receiving no sedation had • More days without ventilation (13.8 vs 9.6 days, P = 0.02) • Shorter stay in ICU (HR 1.86, P = 0.03) • Shorter stay in hospital (HR 3.57, P = 0.004) • More agitated delirium (N = 11, 20% vs N = 4, 7%, P = 0.04) • No differences found in • Accidental extubations • Need for CT or MRI • Ventilator-associated pneumonia Strøm T, et al. Lancet. 2010;375:475-480.

  43. Benzodiazepines vs PropofolBetter Outcomes With Propofol Ely EW, et al. Chest. 2012;142(2);287-289.

  44. Benzodiazepines vsPropofol Ely EW, et al. Chest. 2012;142(2);287-289.

  45. Benzodiazepines vsDexmedetomidine Ely EW, et al. Chest. 2012;142(2);287-289.

  46. MENDS: Dexmedetomidine vs Lorazepam • Double-blind RCT of dex (0.15–1.5 mcg/kg/hr) vs lorazepam (1–10 mg/hr) • Titrated to sedation goal (using RASS) established by ICU team • Dexmedetomidine resulted in more time spent within sedation goals than lorazepam (P = 0.04). Differences in 28-day mortality and delirium-free days were not significant • While incidence of HR ≤ 60 was greater with Dex (17 vs 4%, P = 0.03, the incidence of HR ≤ 40 was not different (2 vs 2%) Pandharipande PP, et al. JAMA. 2007;298(22) 2644-2653.

  47. SEDCOM: Dexmedetomidine vsMidazolam • Double-blind, randomized, multicenter trial comparing long-term (> 24 hr) dexmedetomidine (n = 244) with midazolam (n = 122) • Sedatives (DEX 0.2-1.4 μg/kg/hr or MDZ 0.02-0.1 mg/kg/hr) titrated for light sedation (RASS -2 to +1), administered up to 30 days • All patients underwent daily arousal assessments and drug titration Q 4 hours P-Value Outcome Midazolam (N = 122) DEX (N = 244) Time in target sedation range, % 75.1 77.3 0.18 Duration of sedation, days 4.1 3.5 0.01 Time to extubation, days 5.6 3.7 0.01 49 63 0.02 Patients receiving open-label, % midazolam 18.9 42.2 0.001 Bradycardia, % Bradycardia requiring intervention, % 0.8 0.07 4.9 Riker RR, et al. JAMA. 2009;301(5):489-499.

  48. MIDEX and PRODEX Trials • 2 phase 3 multicenter RCTs • Dexmedetomidine vs midazolam (MDZ) or propofol • ~ 250 patients per arm, MV > 24 hours • Daily interruption of sedation, SBT Jakob SM, et al. JAMA. 2012;307:1151-1160.

  49. Pain, Agitation, and Delirium Are Interrelated Pain Agitation Delirium Barr J, et al. CritCare Med. 2013;41:263-306.

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