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The ABCDE Bundle Sedation in the ICU from A to E.

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1 The ABCDE Bundle Sedation in the ICU from A to E

2 Director Cardio-vascular Anesthesia Westchester Medical Center Assistant Professor Dept. of Anesthesiology New York Medical College Immediate Past President New York State Society of Anesthesiologists Salvatore Vitale M.D.

3 TAVR Team Westchester Medical Center

4 Describe current guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit Use validated scales to measure sedation, pain, agitation, and delirium in critically ill patients Compare the benefits and limitations of available sedatives and analgesics in the acute care, procedural, and surgical settings Learning Objectives

5 Prevent pain and anxiety Decrease oxygen consumption Decrease the stress response Patient-ventilator synchrony Avoid adverse neurocognitive sequelae –Depression –PTSD –Dementia –Anxiety Goals for Sedation and Analgesia 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.

6 Jacobi J, et al. Crit Care Med. 2002;30:119-141 Guideline focus –Prolonged sedation and analgesia –Patients older than 12 years –Patients during mechanical ventilation Assessment and treatment recommendations –Analgesia –Sedation –Delirium –Sleep American College of Critical Care Medicine (ACCM) Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult

7 Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233 ABCDE bundle is designed to: –Standardize care processes –Break the cycle of oversedation and prolonged ventilation What Is the ABCDE Bundle?

8 1.Awakening and Breathing Trial coordination 2.Coordination/Choice of Sedation 3.Delirium Monitoring and Management 4.Early Mobility What Is in the ABCDE Bundle? Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233.

9 Awakening Breathing Coordination/Choice of Sedation Delirium Monitoring and Management Early Mobilization ABCDE

10 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 Daily Sedation Interruption (DSI) Decreases Duration of Mechanical Ventilation Kress JP, et al. N Engl J Med. 2000;342:1471-1477. 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

11 To determine the efficacy and safety of a protocol linking: spontaneous awakening trials (SATs) & spontaneous breathing trials (SBTs) –Ventilator-free days –Duration of mechanical ventilation –ICU and hospital length of stay –Duration of coma and delirium –Long-term neuropsychological outcomes The ABC Trial: Objectives Girard TD, et al. Lancet. 2008;371:126-134.

12 ABC Trial: Main Outcomes Outcome* SBT SAT+SBT P-value Ventilator-free days 12 15 0.02 Time-to-Event, days Successful extubation, days 7.050.05 ICU discharge, days 1390.02 Hospital discharge, days 19150.04 Death at 1 year, n (%) 97 (58%) 74 (44%)0.01 Days of brain dysfunction Coma 3.02.00.002 Delirium 2.0 0.50 * Median, except as noted Girard TD, et al. Lancet. 2008;371:126-134.

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

14 Canada – 40% get SATs (273 physicians in 2005) 1 US – 40% get SATs (2004-05) 2 Germany – 34% get SATs (214 ICUs in 2006) 3 France – 40–50% deeply sedated with 90% on continuous infusion of sedative/opiate 4 Daily Sedation Interruption (DSI) Not Standard of Practice at Most Institutions 1. Mehta S, et al. Crit Care Med. 2006;34:374-380. 2. Devlin J. Crit Care Med. 2006;34:556-557. 3. Martin J, et al. Crit Care. 2007;11:R124. 4. Payen JF, et al. Anesthesiology. 2007;106:687-695.

15 Number of respondents (%) Clinicians preferring propofol were more likely use daily interruption than those preferring benzodiazepines (55% vs 40%, P < 0.0001) Tanios MA, et al. J Crit Care. 2009;24:66-73. 010203040506070 #1 Barrier #2 Barrier #3 Barrier Increased device removal Poor nursing acceptance Compromises patient comfort Leads to respiratory compromise Difficult to coordinate with nurse No benefit Leads to cardiac ischemia Leads to PTSD Barriers to Daily Sedation Interruption (Survey of 904 SCCM members)

16 Awakening Trial No active seizures No active alcohol withdrawal No active agitation No active paralytic use No myocardial ischemia (24h) Normal intracranial pressure Breathing Trial No active agitation Oxygen saturation ≥ 88% FiO 2 ≤ 50% PEEP ≤ 8 cm H 2 O No myocardial ischemia (24h) Normal intracranial pressure No significant vasopressor or inotrope use Awakening and Breathing (AB) Safety Screens Girard TD, et al. Lancet. 2008;371(9607):126-134.

17 Awakening Breathing Coordination/Choice of Sedation Delirium Monitoring and Management Early Mobilization ABCDE

18 Oversedation Prolonged mechanical ventilation Increased length of stay Increased risk of complications - Ventilator-associated pneumonia Increased diagnostic testing Inability to evaluate for delirium Undersedation Patient recall Device removal Ineffectual mechanical ventilation Initiation of neuromuscular blockade Myocardial or cerebral ischemia Decreased family satisfaction w/care Patient Comfort and Ventilatory Optimization GOALGOAL Jacobi J, et al. Crit Care Med. 2002;30:119-141. ICU Sedation: The Balancing Act

19 Continuous sedation carries the risks associated with oversedation and may increase the duration of mechanical ventilation (MV) 1 MV patients accrue significantly more cost during their ICU stay than non-MV patients 2 –$31,574 versus $12,931, P < 0.001 Sedation should be titrated to achieve a cooperative patient and daily wake-up, a JC requirement 1,2 Targeted Sedation 1. Kress JP, et al. N Engl J Med. 2000;342:1471-1477. 2. Dasta JF, et al. Crit Care Med. 2005;33:1266-1271. 3. Kaplan LJ, Bailey H. Crit Care. 2000;4(suppl 1):P190. Undersedated 3 Oversedated On Target 15.4% 54.0% 30.6%

20 Assessing Agitation and Sedation Richmond Agitation-Sedation Scale (RASS) Sessler CN, et al. Am J Respir Crit Care Med. 2002;166(10):1338-1344. Ely EW, et al. JAMA. 2003;289:2983-2991 Sedation-Agitation Scale (SAS) Riker RR, et al. Crit Care Med. 1999;27:1325-1329. Brandl K, et al. Pharmacotherapy. 2001;21:431-436.

21 ScoreTermDescription +4 Combative Overtly combative, violent, immediate danger to staff +3 Very agitatedPulls or removes tube(s) or catheter(s); aggressive +2Agitated Frequent non-purposeful movement, fights ventilator +1 Restless Anxious but movements not aggressive vigorous 0Alert and calm Drowsy Not fully alert, but has sustained awakening (eye- opening/eye contact) to voice (>10 seconds) -2 Light sedation Briefly awakens with eye contact to voice (<10 seconds) -3Moderate sedation Movement or eye opening to voice (but no eye contact) -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation -5 Unarousable No response to voice or physical stimulation Richmond Agitation Sedation Scale (RASS) *

22 1. Observe patient –Patient is alert, restless, or agitated. (score 0 to +4) 2. If not alert, state patient’s name and say to open eyes and look at speaker. –Patient awakens with sustained eye opening and eye contact. (score –1) –Patient awakens with eye opening and eye contact, but not sustained. (score –2) –Patient has any movement in response to voice but no eye contact. (score –3)  3. When no response to verbal stimulation, physically stimulate patient by shaking shoulder and/or rubbing sternum. –Patient has any movement to physical stimulation. (score –4) –Patient has no response to any stimulation. (score –5) Procedure for RASS Assessment

23 Rapid onset of action allows rapid recovery after discontinuation Effective at providing adequate sedation with predictable dose response Easy to administer Lack of drug accumulation Few adverse effects Minimal adverse interactions with other drugs Cost-effective Promotes natural sleep Characteristics of an Ideal Sedative Ostermann ME, et al. JAMA. 2000;283:1451-1459. Jacobi J, et al. Crit Care Med. 2002;30:119-141. Dasta JF, et al. Pharmacother. 2006;26:798-805. Nelson LE, et al. Anesthesiol. 2003;98:428-436.

24 Chronic pain Organ dysfunction CV instability Substance withdrawal Respiratory insufficiency Obesity Obstructive sleep apnea Patient Comorbidities to Consider

25 Overview of Presently available Intravenous Agents

26   Agonist Propofol Acetaminophen NSAIDs Haldol The Good

27 Opiates Benzodiazepines The Bad

28 The Ugly Flumazenil Naloxone

29 The Good

30 Dexmedetomidine a 2 Agonist Hypotension Hypertension Nausea Bradycardia Dry mouth Peripheral vasoconstriction at high doses Antihypertensive Sedation Analgesia Decreased shivering Anxiolysis Patient arousability Potentiate effects of opioids, sedatives, and anesthetics Decrease sympathetic activity Adverse Effects Clinical Effects Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349. Bhana N, et al. Drugs. 2000;59(2):263-268.

31 Propofol Sedation Hypnosis Anxiolysis Muscle relaxation Mild bronchodilation Decreased ICP Decreased cerebral metabolic rate Antiemetic Ellett ML. Gastroenterol Nurs. 2010;33(4):284-925. Lundström S, et al. J Pain Symptom Manage. 2010;40(3):466-470. Clinical Effects Adverse Effects Pain on injection Respiratory depression Hypotension Decreased myocardial contractility Increased serum triglycerides Tolerance Propofol infusion syndrome Prolonged effect with high adiposity Seizures (rare)

32  Available in po and IV forms  Demonstrated effective relief of pain, either alone (mild to moderate pain) or as part of a multimodal regimen (moderate to severe pain)  No delerium  Peak effect: within an hour of administration  Duration of effect: 4 to 6 hours  No significant effect on platelet aggregation 5 Acetaminophen Potential Hepatotoxicity Antipyretic effects may mask fever in patients treated for post-surgical pain Clinical Effects Adverse Effects

33 Lacks respiratory depression Good pain control NSAIDS Ketorolac and Ibuprofen Anti platelet activity Black box warning for cardiac patients

34 Hypnotic agent with antipsychotic properties 1 For treatment of delirium in critically ill adults 1 Does not cause respiratory depression 1 Haloperidol Dopamine Antagonist Clinical EffectsAdverse Effects Dysphoria 2 Adverse CV effects include QT interval prolongation Extrapyramidal symptoms, neuroleptic malignant syndrome (rare)1 Metabolism altered by drug- drug interactions 2 1. Harvey MA. Am J Crit Care. 1996;5:7-16. 2. Crippen DW. Crit Care Clin. 1990;6:369-392.

35 The Bad

36 Opioids Hypotension Bradycardia Respiratory depression Tolerance Constipation Withdrawal symptoms Hormonal changes Sedation Analgesia Adverse EffectsClinical Effects Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S105-120. Fentanyl Morphine Remifentanyl

37 Clinical Effects Sedation, anxiolysis, and amnesia Commonly used for long- term sedation Benzodiazepines Adverse Effects Metabolic acidosis (propylene glycol vehicle toxicity) Retrograde and anterograde amnesia Delirium Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360. Wilson KC, et al. Chest. 2005;128(3):1674-1681. Lorazapam Midazolam

38 Comparison of Clinical Effects 1. Blanchard AR. Postgrad Med. 2002;111:59-74. 2. Kamibayashi T, et al. Anesthesiol. 2000;95:1345-1349. 3. Maze M, et al. Anesthetic Pharmacology: Physiologic Principles and Clinical Practice. Churchill Livingstone; 2004. 4. Maze M, et al. Crit Care Clin. 2001;17:881-897. XX Alleviate anxiety 1,2 XX Control delirium 1-4 X Facilitate ventilation during weaning 2-4 X Promote arousability during sedation 2-4 XX Analgesic properties 1-4 XXXXX Sedation Haloperidol  2 Agonists OpioidsPropofolBenzodiazepines X

39 Comparison of Adverse Effects 1. Harvey MA. Am J Crit Care. 1996;5:7-18. 2. Aantaa R, et al. Drugs of the Future. 1993;18:49-56. 3. Maze M, et al. Crit Care Clin. 2001;17:881-897. XXX Respiratory depression 1 XX Bradycardia 1 Tachycardia 1 X X X Deliriogenic X Constipation 1 XXXXX Hypotension 1-3 X *XX Prolonged weaning 1 Haloperidol Opioids PropofolBenzodiazepines *Excluding remifentanil X  2 Agonists X

40 The Ugly

41 Flumazenil reverses the effects of sedatives from the benzodiazepine group of drugs. Flumazenil

42 An opioid antagonist drug developed in the 1960s. Naloxone is a drug used to counter the effects of opiate overdose, for example heroin or morphine overdose. Use with caution in the opioid addicted patient It is not to be confused with naltrexone, an opioid receptor antagonist with qualitatively different effects, used for dependence treatment rather than emergency overdose treatment. Naloxone

43 Awakening Breathing Coordination/Choice of Sedation Delirium Monitoring and Management Early Mobilization ABCDE

44 Morandi A, et al. Intensive Care Med. 2008;34:1907-1915. Cardinal Symptoms of Delirium and Coma

45 Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233. Develops in ~2/3 of critically ill patients Hypoactive or mixed forms most common Increased risk – Benzodiazepines – Extended ventilation – Immobility Associated with weakness Undiagnosed in up to 72% of cases ICU Delirium

46 Patient Factors Increased age Alcohol use Male gender Living alone Smoking Renal disease Environment Admission via ED or through transfer Isolation No clock No daylight No visitors Noise Physical restraints Predisposing Disease Cardiac disease Cognitive impairment (eg, dementia) Pulmonary disease Acute Illness Length of stay Fever Medicine service Lack of nutrition Hypotension Sepsis Metabolic disorders Tubes/catheters Medications: - Anticholinergics - Corticosteroids - Benzodiazepines Less Modifiable DELIRIUM Van Rompaey B, et al. Crit Care. 2009;13:R77. Inouye SK, et al. JAMA.1996;275:852-857. Skrobik Y. Crit Care Clin. 2009;25:585-591. More Modifiabl e

47 Mechanisms for Delirium in the Critically Ill: Numerous and Not Clearly Understood Maldonado JR. Crit Care Clin. 2008;24(4):789-856. Pandharipande PP. Intensive Care Med. 2009;35(11):1886-1892. Adams-Wilson JR, et al. Crit Care Med. 2012 (in press) Neurotransmitter imbalance Neuroinflammation Blood brain barrier permeability Impaired oxidative metabolism Microglial activation Abnormal levels of large neutral amino acids (eg, tryptophan) and their metabolism (eg, kynurenine pathway)

48 After Hospital Discharge During the ICU/Hospital Stay Sequelae of Delirium Increased mortality Longer intubation time Average 10 additional days in hospital Higher costs of care Increased mortality Development of dementia Long-term cognitive impairment Requirement for care in chronic care facility Decreased functional status at 6 months Bruno JJ, Warren ML. Crit Care Nurs Clin North Am. 2010;22(2):161-178. Shehabi Y, et al. Crit Care Med. 2010;38(12):2311-2318. Rockwood K, et al. Age Ageing. 1999;28(6):551-556. Jackson JC, et al. Neuropsychol Rev. 2004;14:87-98. Nelson JE, et al. Arch Intern Med. 2006;166:1993-1999.

49 Delirium Duration and Mortality Pisani MA. Am J Respir Crit Care Med. 2009;180:1092-1097. Kaplan-Meier Survival Curve Each day of delirium in the ICU increases the hazard of mortality by 10% P < 0.001

50 Duration of delirium was an independent predictor of cognitive impairment –An increase from 1 day of delirium to 5 days was associated with nearly a 5-point decline in cognitive battery scores Worse Long-term Cognitive Performance Girard TD, et al. Crit Care Med. 2010;38:1513-1520. Misak CJ. Am J Respir Crit Care Med. 2004;170(4):357-359.

51 Benzodiazepine use 4,10 Coma (medical vs. pharmacologic) 4,9 Morphine use ( ?data unclear ) Risk Factors Specific for ICU Delirium 1.Pisani MA, et al. Crit Care Med. 2009;37:177-183 2.Pisani MA, et al. Arch Intern Med. 2007;167:1629-1634. 3.Van Rompaey B, et al. Crit Care. 2009;13:R77. 4.Ouimet S, et al. Intensive Care Med. 2007;33:66-73. 5.Dubois MJ, et al. Intensive Care Med. 2001;27:1297-1304. 6.Pandharipande PP, et al. Anesthesiology. 2006;104:21-26. 7.Pisani MA, et al. Crit Care Med. 2009;37:177-183. 8.Pandharipande PP, et al. Intensive Care Med. 2009;35:1886-1892. 9.Ely EW, et al. Crit Care Med. 2007;35:112-117. 10.Pandharipande PP, et al. J Trauma. 2008;65:34-41. Dementia 1,2,3 Hypertension history 4,5 Alcoholism 3,4 Severity of illness 1,4,6,7,8 Age (?pos 6,8 /neg 2,3,4,9 )

52 Confusion Assessment Method for the ICU (CAM-ICU) –Ely EW, et al. Crit Care Med. 2001;29:1370- 1379. –Ely EW, et al. JAMA. 2001;286:2703-2710. Intensive Care Delirium Screening Checklist (ICDSC) –Bergeron N, et al. Intensive Care Med. 2001;27:859-864. –Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013. Delirium Assessment Tools

53

54 Confusion Assessment Method (CAM-ICU) or 3. Altered level of consciousness 4. Disorganized thinking = Delirium Ely EW, et al. Crit Care Med. 2001;29:1370-1379. Ely EW, et al. JAMA. 2001;286:2703-2710. 1. Acute onset of mental status changes or a fluctuating course 2. Inattention and

55

56 Confusion Assessment Method for the ICU (CAM-ICU) –Ely EW, et al. Crit Care Med. 2001;29:1370-1379. –Ely EW, et al. JAMA. 2001;286:2703-2710. Intensive Care Delirium Screening Checklist (ICDSC) –Bergeron N, et al. Intensive Care Med. 2001;27:859-864. –Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013. Delirium Assessment Tools

57 1. Altered level of consciousness 2. Inattention 3. Disorientation 4. Hallucinations 5. Psychomotor agitation or retardation 6. Inappropriate speech 7. Sleep/wake cycle disturbances 8. Symptom fluctuation Intensive Care Delirium Screening Checklist Bergeron N, et al. Intensive Care Med. 2001;27:859-864. Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013. Score 1 point for each component present during shift Score of 1-3 = Subsyndromal Delirium Score of ≥ 4 = Delirium

58 Stop THINK Lastly, medicate Helpful Approach to Delirium Management

59 Do any meds need to be stopped or lowered? Especially consider sedatives Is patient on minimal amount necessary? –Daily sedation cessation –Targeted sedation plan Do sedatives need to be changed? Stop and THINK Toxic Situations CHF, shock, dehydration Deliriogenic meds (tight titration) New organ failure (liver/kidney) Hypoxemia Infection/sepsis (nosocomial) Immobilization Nonpharm interventions Hearing aids, glasses, reorient, sleep protocols, music, noise control, ambulation K + or electrolyte problems

60 Early mobility – the only nonpharmacologic intervention shown to reduce ICU delirium 1 Other interventions: –Environmental changes (eg, noise reduction) –Sensory aids (eg, hearing aids, glasses) –Reorientation and stimulation –Sleep preservation and enhancement Delirium Nonpharmacologic Interventions Schweickert WD, et al. Lancet. 2009;373:1874-1882.

61 Sleep Abnormalities in the ICU More time in light sleep Less time in deep sleep More sleep fragmentation Friese R. Crit Care Med. 2008;36:697-705. Weinhouse GL, Watson PL. Crit Care Clin. 2009;25:539-549. There is little evidence that sedatives in the ICU restore normal sleep

62 Optimize environmental strategies –Day/night variation, reduce night interruptions, noise reduction Avoid benzodiazepines (↓ Slow wave sleep (SWS) & REM) Consider dexmedetomidine (↑ SWS) GABA receptor agonists (eg, zolpidem) Sedating antidepressants (eg, trazodone) or antipsychotics Melatonin –Pilot: may improve sleep quality of ICU COPD patients Boosting Sleep Quality in ICU Weinhouse GL, Watson PL. Crit Care Clinics. 2009;25:539-549. Faulhaber J, et al. Psychopharmacology. 1997;130:285-291. Shilo L, et al. Chronobiol Int. 2000;17:71-76.

63 There is little evidence that administration of sedatives in the ICU achieves the restorative function of normal sleep Benzodiazepines ↑ Stage 2 NREM ↓ Slow wave sleep (SWS) and REM Propofol ↑ Total sleep time without enhancing REM ↓ SWS Analgesics Abnormal sleep architecture Dexmedetomidine ↑ SWS Effect of Common Sedatives and Analgesics on Sleep Weinhouse GL, et al. Sleep. 2006;29:707-716. Nelson LE, et al. Anesthesiology. 2003;98:428-436.

64 Targeted Risk FactorStandardized Intervention Cognitive impairment Orientation & therapeutic activity protocol (discuss current events, word games, reorient, etc) Sleep deprivation Sleep enhancement & nonpharm sleep protocol (noise reduction, back massages, schedule adjustment) Immobility Early mobilization protocol (active ROM, reduce restraint use, ambulation, remove catheters) Visual impairment Vision protocol (glasses, adaptive equipment, reinforce use) Hearing impairment Hearing protocol (amplification devices, hearing aids, earwax disimpaction) Dehydration Dehydration protocol (early recognition of dehydration & volume repletion) Elder Life Program Inouye SK, et al. N Engl J Med. 1999;340:669-676.

65 Outcome Interventi on Control P- value Incidence of delirium, N (%) 42 (9.9)64 (15)0.02 Total days of delirium1051610.02 Episodes of delirium62900.03 Results ↓ delirium incidence in patients with intermediate baseline risk Improved orientation score with targeted intervention (P = 0.04) Reduced rate of sedative use for sleep (P = 0.001) 87% overall adherence to protocol Inouye SK, et al. N Engl J Med. 1999;340:669-676.

66 Haloperidol Dopamine Antagonist Adverse CV effects include QT interval prolongation Extrapyramidal symptoms, Neuroleptic malignant syndrome (rare) 1 Does not cause respiratory depression 1 Dysphoria 2 Hypnotic agent with antipsychotic properties 1 Adverse Effects Clinical Effects 1. Harvey MA. Am J Crit Care. 1996;5:7-16. 2. Crippen DW. Crit Care Clin. 1990;6:369-392. –For treatment of delirium in critically ill adults 1 Metabolism altered by drug-drug interactions 2

67 However, ventricular tachyarrhythmia was not detected among 307 patients within a 1 ­year period, although the ECG was continuously monitored for at least 8 hours after intravenous HAL. The modest nature of QTc prolongation and the apparent absence of ventricular tachyarrhythmia under continuous ECG monitoring indicate that QTc prolongation associated with intravenous HAL is not necessarily dangerous. However, in an emergency situation, clinicians cannot exclude patients predisposed to torsade de pointes, such as those with inherited ion channel disorders. Therefore, clinicians should be aware of the association between intravenous HAL and QT prolongation Association Between Intravenous Haloperidol & Prolonged QT Interval

68 Receptor adherence is variable between agents Use has increased substantially Possible safety benefits –Decreased extrapyramidal effects –Little effect on the QTc interval (except ziprasidone) –Less hypotension/fewer orthostatic effects –Less likely to cause neuroleptic malignant syndrome Possible limitations –No IV formulations available –Little published experience in ICU patients –Troublesome reports of adverse events but most associated with prolonged use in non-delirium patients Atypical Antipsychotics Devlin JW, et al. Harv Rev Psychiatry. 2011;19:59-67.

69 Amisulpride (Solian) Aripiprazole (Abilify) Asenapine (Saphris) Blonanserin (Lonasen) Carpipramine (Prazinil) Clocapramine (Clofekton) Clotiapine (Entumine) Clozapine (Clozaril) Iloperidone (Fanapt) Lurasidone (Latuda) Mosapramine (Cremin) Olanzapine (Zyprexa) Paliperidone (Invega) Perospirone (Lullan) Quetiapine (Seroquel) Remoxipride (Roxiam) Risperidone (Risperdal) Sertindole (Serdolect) Sulpiride (Sulpirid, Eglonyl) Ziprasidone (Geodon, Zeldox) Zotepine (Nipolept) List of Atypical Antipsychotics

70 Use of Atypical Antipsychotic Therapy Is Increasing Ely EW, et al. Crit Care Med. 2004;32:106-112. Patel RP, et al. Crit Care Med. 2009;37:825-832. 0 10 20 30 40 50 60 70 80 90 Atypical Antipsychotics Benzodiazepines Haloperidol Propofol 2001 2007 Respondents, %

71 RCT of short-term low-dose IV haloperidol Patients –N = 457 –Age > 65 years –ICU after noncardiac surgery Intervention –Haloperidol  0.5 mg IV bolus then  Infusion 0.1 mg/h for 12 hrs –Placebo Primary endpoint –Incidence of delirium within the first 7 days after surgery Prophylactic Haloperidol Wang W, et al. Crit Care Med. 2012;40(3):731-739.

72 Prophylactic Haloperidol Wang W, et al. Crit Care Med. 2012;40(3):731-739. Haloperidol (n = 229) Placebo (n = 229) P-value 7 day delirium incidence (%) 15.323.20.031 Mean time to delirium onset (days) 6.25.70.021 Mean time delirium-free (days) 6.86.70.027 Median ICU LOS (hours) 21.323.00.024 All-cause 28-day mortality (%) 0.92.60.175

73 Randomized, double-blind, placebo-controlled Multisite (3 centers) 36 ICU patients PO delivery of study drug Quetiapine dose: 50-200 mg q12h Primary outcome: time to first resolution of delirium (ie, first 12-hour period when ICDSC ≤ 3) Quetiapine vs. Placebo Quetiapine (n = 18)Placebo (n = 18) Delirium + Haloperidol PRN Devlin JW, et al. Crit Care Med. 2010;38(2):419-427.

74 Placebo Quetiapine Proportion of Patients with Delirium Day During Study Drug Administration Log-Rank P = 0.001 Quetiapine added to as-needed haloperidol results in faster delirium resolution, less agitation, and a greater rate of transfer to home or rehabilitation. Devlin JW, et al. Crit Care Med. 2010;38:419-427. Patients with First Resolution of Delirium

75 QuetiapinePlaceboP value Median time to symptom resolution Log rank Inattention3 hrs8 hrs0.10 Disorientation2 hrs10 hrs0.10 Symptom fluctuation 4 hrs14 hrs0.004 Agitation5 hrs1 hrs0.04 Time with each symptom [median (IQR)] Comparison of Proportions Inattention47 (0-67)%78 (43-100)%0.02 Hallucinations0 (0-17)%28 (0-43)%0.10 Symptom fluctuation 47 (19-67)%89 (33-100)%0.04 Impact of Quetiapine on the Resolution of Individual Delirium Symptoms Median ICDSC and individual delirium symptoms similar at study baseline Devlin JW, et al. Crit Care. 2011;15(5):R215.

76 http://www.accessdata.fda.gov. Accessed March 2012. Van Eijk MM, et al. Lancet. 2010;376(9755):1829-1837. Rivastigmine for Delirium? FDA approved for dementia of Alzheimer’s or Parkinson’s Cholinesterase inhibitor Result −Mortality (vs placebo): 22% vs 8%, P = 0.07 −Delirium (vs placebo): 5 vs 3 days, P = 0.06 Conclusion: −Need RCTs for delirium as endpoint −Don’t use rivastigmine for ICU delirium Time (days after inclusion) Survival (%)

77 Does your patient have delirium? –Assessed with scale? Which type of delirium? –Hyperactive –Hypoactive –Mixed hyperactive-hypoactive Have the underlying causes of delirium been identified and reversed/treated? Have non-pharmacologic strategies been optimized? Before Considering a Pharmacologic Treatment for Delirium… Inouye SK, et al. N Engl J Med. 1999;340:669-676.

78 Antipsychotics. http://www.canhr.org/ToxicGuide/Media/Articles/FDA%20Alert%20on%20Antipsychotics.pdf. Accessed March 2012. Antipsychotic Therapy Rule Out Dementia Antipsychotic drugs are not approved for the treatment of dementia-related psychosis No drug is approved for dementia-related psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death Physicians considering antipsychotics for elderly patients with dementia-related psychosis should discuss this increased risk of mortality with their patients, patients’ families, and caregivers

79 Awakening Breathing Coordination/ Choice of Sedation Delirium Monitoring and Management Early Mobilization ABCDE

80 Early Mobilization Patient Selection Inclusion criteria −Medical ICU −Adults (≥ 18 years of age) −On MV < 72 h, expected to continue for at least 24 h −Met criteria for baseline functional independence (Barthel Index score ≥ 70) Exclusion criteria −Rapidly developing  Neuromuscular disease  Cardiopulmonary arrest  Irreversible disorders with estimated 6-month mortality > 50%  Raised intracranial pressure  Absent limbs  Enrollment in another trial Schweickert WD, et al. Lancet. 2009;373:1874-1882.

81 Early Mobilization Trial Design 104 sedated patients with daily interruption –Early exercise and mobilization (PT & OT; intervention; n = 49) –PT & OT as ordered by the primary care team (control; n = 55) Primary endpoint: number of patients returning to independent functional status at hospital discharge –Ability to perform 6 activities of daily living –Ability to walk independently Assessors blinded to treatment assignment Secondary endpoints –Duration of delirium during first 28 days of hospital stay –Ventilator-free days during first 28 days of hospital stay Schweickert WD, et al. Lancet. 2009;373:1874-1882.

82 Perform Safety Screen First Schweickert WD, et al. Lancet. 2009;373:1874-1882. PassFail Exercise/Mobility Therapy Too Ill for Exercise/Mobility *Range of motion may be started in comatose patients, but not considered Early Exercise/Mobility

83 Early Mobilization Protocol: Result Schweickert WD, et al. Lancet. 2009;373:1874-1882. Return to independent functional status at discharge –59% in intervention group –35% in control group (P = 0.02)

84 Early PT and OT in Mechanically Ventilated ICU Patients Schweickert WD, et al. Lancet. 2009;373(9678):1874-1882. P = 0.02 P = 0.08 P = 0.02 P = 0.93 All Patients

85 Protocol for Early Mobility Therapy Acute Respiratory Failure Patients Morris PE, et al. Crit Care Med. 2008;36(8):2238-2243.

86 Early Mobility Therapy Results Morris PE, et al. Crit Care Med. 2008;36(8):2238-2243. Usual Care* (n = 135) Protocol* (n = 145) P-Value Days to first out of bed 11.35.00.001 Ventilator days 10.28.80.163 ICU LOS days 6.95.50.025 Hospital LOS days 14.511.20.006 Primary Endpoint: more protocol patients received PT than did usual care (80% vs. 47%, P ≤ 0.001) * Values adjusted for BMI, Acute Physiology & Chronic Health Evaluation II, and vasopressor

87 SCCM Task Force on Long-Term Outcomes “Post-intensive care syndrome (PICS) was agreed upon as the recommended term to describe new or worsening problems in physical, cognitive, or mental health status arising after a critical illness and persisting beyond acute care hospitalization. The term could be applied to either a survivor or family member- PICS-F.” Post-Intensive Care Syndrome (PICS) Needham DM, et al. Crit Care Med. 2012;40(2):502-509.

88 Post Intensive Care Syndrome (PICS) Family (PICS-F) Mental Health Anxiety/ASD PTSD Depression Complicated Grief Survivor (PICS) Mental Health Anxiety/ASD PTSD Depression Cognitive Impairments Executive Function Memory Attention Physical Impairments Pulmonary Neuromuscular Physical Function Needham DM, et al. Crit Care Med. 2012;40(2):502-509. Desai SV, et al. Crit Care Med. 2011;39(2):371-379. Davidson JE, et al. Crit Care Med. 2012;40(2):618-624. PICS Consequences

89 Morandi A, et al. Curr Opin Crit Care. 2011;17:43-49. Benefits of ABCDE Protocol

90 Multidisciplinary team focused on reducing heavy sedation, using SAT-SBT protocol and increasing MICU staffing to include full-time physical and occupational therapists with new consultation guidelines Results: –Delirium decreased –Sedation use decreased –Physical mobility improvement –Decrease hospital length of stay –Increased MICU admissions Quality Improvement Project: Implementing ABCDE Needham DM, et al. Arch Phys Med Rehabil. 2010;91(4):536-542. Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.

91 Results of ICU Quality Initiative Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.

92 Results of ICU Quality Initiative (cont) Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.

93 Untargeted sedation in the ICU is common, and it is associated with negative sequelae Be familiar with the ABCDE protocol Titrate all sedative medications using a validated assessment tool to keep patients comfortable and arousable if possible Use of benzodiazepines should be minimized Conclusions

94 Consider nonpharmacological management of delirium and reduce exposure to risk factors Typical and atypical antipsychotic medications may be used to treat delirium if nonpharmacological interventions are not adequate Early mobility in ICU patients decreases delirium and improves functional outcomes at discharge Recognize PICS exists for patients and families Conclusions

95 Thanks


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