learning objectives describe current guidelines for the management of pain, agitation, and delirium...
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Learning Objectives
• 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
Goals for Sedation and Analgesia
• Prevent pain and anxiety• Decrease oxygen consumption• Decrease the stress response• Patient-ventilator synchrony• Avoid adverse neurocognitive sequelae
– Depression– PTSD– Dementia– Anxiety
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.
American College of Critical Care Medicine Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult
• Guideline focus – Prolonged sedation and analgesia– Patients older than 12 years– Patients during mechanical ventilation
• Assessment and treatment recommendations – Analgesia – Sedation– Delirium– Sleep
• Update expected in 2012
Jacobi J, et al. Crit Care Med. 2002;30:119-141.
American College of Critical Care Medicine (ACCM) Guidelines
• Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult
• Pertains to patients older than 12 years during mechanical ventilation
• Areas of focus– Assessment for pain, delirium– Physiological monitoring – Pharmacologic tools
• Most recommendations rated as grade B or C
Jacobi J, et al. Crit Care Med. 2002;30:119-141.
Assessing Pain: FACES Scale 0–10
Wong DL, et al. Wong’s Essentials of Pediatric Nursing. 6th ed. St. Louis, MO: Mosby, Inc; 2001. p.1301.
Other Scales• Behavioral Pain Scale (BPS) 3-12
– Payen JF, et al. Crit Care Med. 2001;29(12):2258-2263.
• Critical Care Pain Observation Tool 0-8– Gélinas C, et al. Am J Crit Care. 2006;15:420-427.
Managing Pain in the ICU: Opioids
• Hormonal changes
• Withdrawal symptoms
• Tolerance
• Constipation
• Bradycardia
• Hypotension• Sedation
• Respiratory depression• Analgesia
Adverse EffectsClinical Effects
Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S105-120.
Fentanyl
Morphine
Remifentanil
What Is the ABCDE Bundle?We Need Coordinated Care
• Many tasks and demands on critical care staff• Great need to align and support the people,
processes, and technology already in ICUs • ABCDE bundle is multicomponent,
interdependent, and designed to: – Improve clinical team collaboration – Standardize care processes– Break the cycle of oversedation and prolonged
ventilation
Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233.
What Is the ABCDE Bundle?
Awakening and Breathing Trial coordination
Coordination/Choice of Sedation
Delirium Monitoring and Management
Early Mobility
Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233.
Awakening BreathingCoordination/Choice of SedationDelirium Monitoring and ManagementEarly Mobilization
ABCDE
ICU Sedation: The Balancing Act
Oversedation
• Prolonged mechanical ventilation• Increase 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
GOAL
Jacobi J, et al. Crit Care Med. 2002;30:119-141.
Improper Sedation
• 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 patients2
– $31,574 versus $12,931, P < 0.001
• Sedation should be titrated to achieve a cooperative patient and daily wake-up, a JC requirement1,2
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.
Undersedated3
Oversedated
On Target
15.4%
54.0%
30.6%
Assessing Agitation and Sedation
• Sedation-Agitation Scale (SAS)– Riker RR, et al. Crit Care Med. 1999;27:1325-1329.– Brandl K, et al. Pharmacotherapy. 2001;21:431-436.
• 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.
Systematic Implementation of Pain and Sedation Tools: Montpellier France
Pain Agitation0
10
20
30
40
50
60
70
80
42
12
63
29
Post implemenation n = 130
Control n = 100
Inc
ide
nc
e o
f p
ain
or
ag
ita
tio
n (
%)
P < 0.01
Significant Patient Characteristics/Metrics/Outcomes
Pre Post P-value
Mechanical Ventilation, hrs*
120 65 0.01
Duration CIVS, hrs* 84 48 0.03
Duration CIVI Opioid, hrs*
96 60 0.02
Nosocomial infection†
17 (17)
11 (8) < 0.05
*Data presented in median hrs; †Data presented as n (%)CIVS; Continuous intravenous infusion sedation
Chanques G, et al. Crit Care Med. 2006;34(6):1691-1699.
P < 0.01
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
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
• 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
ABC Trial: Objectives
Girard TD, et al. Lancet. 2008;371:126-134.
ABC Trial: Main Outcomes
Outcome* SBT SAT+SBT P-value
Ventilator-free days 12 15 0.02
Time-to-Event, days
Successful extubation, days 7.0 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.
Despite Proven Benefits of Spontaneous Awakening/Daily Interruption Trials, They Are Not
Standard of Practice at Most Institutions
• 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/opiate4
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.
Number of respondents (%)
Barriers to Daily Sedation Interruption(Survey of 904 SCCM members)
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.
0 10 20 30 40 50 60 70
Leads to PTSD
Leads to cardiac ischemia
No benefit
Difficult to coordinate with nurse
Leads to respiratory compromise
Compromises patient comfort
Poor nursing acceptance
Increased device removal
#1 Barrier
#2 Barrier
#3 Barrier
Awakening and Breathing (AB) Safety Screens
Breathing Trial
• No active agitation• Oxygen saturation ≥ 88%• FiO2 ≤ 50%
• PEEP ≤ 8 cm H2O
• No myocardial ischemia (24h)
• Normal intracranial pressure• No significant vasopressor or
inotrope use
Girard TD, et al. Lancet. 2008;371(9607):126-134.
Awakening Trial • No active seizures• No active alcohol withdrawal• No active agitation• No active paralytic use• No myocardial ischemia (24h)• Normal intracranial pressure
Awakening BreathingCoordination/Choice of SedationDelirium Monitoring and ManagementEarly Mobilization
ABCDE
Characteristics of an Ideal Sedative
• 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
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.
Consider Patient Comorbidities When Choosing a Sedation Regimen
• Chronic pain• Organ dysfunction• CV instability• Substance withdrawal• Respiratory insufficiency• Obesity • Obstructive sleep apnea
GABA AgonistBenzodiazepine Midazolam
• May accumulate with hepatic and/or renal failure
• Anterograde amnesia• Long recovery time• Synergy with opioids • Respiratory depression• Delirium
• Sedation, anxiolysis, and amnesia
• Rapid onset of action (IV)
Adverse EffectsClinical Effects
Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360.Riker RR, et al; SEDCOM Study Group. JAMA. 2009;301(5):489-499.
Clinical Effects• Sedation, anxiolysis, and
amnesia• Commonly used for long-
term sedation
Adverse Effects• Metabolic acidosis (propylene glycol
vehicle toxicity)• Retrograde and anterograde amnesia• Delirium
GABA AgonistBenzodiazepine Lorazepam
Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360.Wilson KC, et al. Chest. 2005;128(3):1674-1681.
GABA Agonist 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)
a2 Agonist Clonidine
•Bradycardia•Dry mouth•Hypotension•Sedation
•Antihypertensive •Analgesia•Sedation•Decrease sympathetic activity•Decreased shivering
Adverse EffectsClinical Effects
Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349.Bergendahl H, et al. Curr Opin Anaesthesiol. 2005;18(6):608-613. Hossmann V, et al. Clin Pharmacol Ther. 1980;28(2):167-176.
a2 Agonist Dexmedetomidine
•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 EffectsClinical Effects
Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349.Bhana N, et al. Drugs. 2000;59(2):263-268.
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.
XXAlleviate anxiety1,2
XXControl delirium1-4
XFacilitate ventilation during weaning2-4
XPromote arousability during sedation2-4
XXAnalgesic properties1-4
XXXXXSedation
Haloperidola2 AgonistsOpioidsPropofolBenzodiazepines
X
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.
XXXRespiratory depression 1
XXfentanylBradycardia 1
morphineTachycardia 1
XXXDeliriogenic
XConstipation 1
XXXXXHypotension 1-3
X *XXProlonged weaning 1
HaloperidolOpioidsPropofolBenzodiazepines
*Excluding remifentanil
X
a2 Agonists
Maximizing Efficacy of Targeted Sedation and Reducing Neurological Dysfunction (MENDS)
• Double-blind RCT of dexmedetomidine vs lorazepam• 103 patients (2 centers)
– 70% MICU, 30% SICU patients (requiring mechanical ventilation > 24 hours)
– Primary outcome: days alive without delirium or coma
• Intervention– Dexmedetomidine 0.15–1.5 mcg/kg/hr– Lorazepam infusion 1–10 mg/hr– Titrated to sedation goal (using RASS) established by ICU team
• No daily interruption
Pandharipande PP, et al. JAMA. 2007;298:2644-2653.
MENDS: Dexmedetomidine vs Lorazepam
Pandharipande PP, et al. JAMA. 2007;298:2644-2653.
• Dexmedetomidine resulted in more days alive without delirium or coma (P = 0.01) and a lower prevalence of coma (P < 0.001) than lorazepam
• 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
Day
s
Lorazepam n = 51
Dexmedetomidine n = 5202
46
81
01
2
P = 0.011
Delirium/Coma-Free Days
Delirium-Free Days
P = 0.086 P < 0.001
Coma-Free Days
OutcomeMidazolam(n = 122)
Dexmedetomidine(n = 244)
P-Value
Time in target sedation range, % (primary EP) 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
Delirium prevalence 93 (76.6%) 132 (54%) 0.001
Delirium-free days 1.7 2.5 0.002
Patients receiving open-label midazolam 60 (49%) 153 (63%) 0.02
• Double-blind, randomized, multicenter trial comparing long-term (> 24 hr) dexmedetomidine (dex, n = 244) with midazolam (mz, n = 122)
• Sedatives (dex 0.2-1.4 μg/kg/hr or mz 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
Riker RR, et al. JAMA. 2009;301:489-499.
SEDCOM: Dexmedetomidine vs Midazolam
Midazolam
Dexmedetomidine
Dexmedetomidine versus Midazolam, P < 0.001
Reduced Delirium Prevalence with Dexmedetomidine vs Midazolam
SEDCOM
Sample Size 118 229 109 206 92 175 77 134 57 92 42 60 44 34
Treatment Day
0
20
40
60
80
100
Baseline 1 2 3 4 5 6
Pa
tien
ts W
ith
De
liriu
m, %
Riker RR, et al. JAMA. 2009;301:489-499.
SEDCOM Trial:Safety Outcomes
OutcomeMidazolam(n = 122)
Dexmedetomidine(n = 244)
P-Value
Bradycardia 18.9% 42.2% 0.001
Tachycardia 44.3% 25.4% 0.001
Hypertension requiring intervention 29.5% 18.9% 0.02
Hyperglycemia 42.6% 56.6% 0.02
Infections 19.7% 10.2% 0.02
Riker RR, et al. JAMA. 2009;301:489-499.
Bradycardia needing treatment 0.8% 4.9% 0.07
MIDEX and PRODEX Trials
Jakob SM, et al. JAMA. 2012;307(11):1151-1160.
• 2 phase 3 multicenter RCTs• Dexmedetomidine vs midazolam (MDZ) or propofol• ~ 250 patients per arm, MV > 24 hours• Daily interruption of sedation, SBT
Arm Time at RASS Target
Median MV, h
ICU LOS, h
Arousability (total VAS)
Hypotension
Brady cardia
MIDEX
MDZ 56.6% 164 243 30.0 11.6% 5.2
Dex 60.7% 123 211 49.7 20.6% 14.2
P-value 0.15 0.03 < 0.001 0.007 < 0.001
PRODEX
Propofol 64.7% 118 185 40.1 13.4% 10.1%
Dex 64.6% 97 164 51.3 13.0% 13%
P-value 0.97 0.24 < 0.001
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.
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.
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.
AwakeningBreathingCoordination/Choice of SedationDelirium Monitoring and ManagementEarly Mobilization
ABCDE
ICU Delirium
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
Patient FactorsIncreased ageAlcohol useMale genderLiving aloneSmokingRenal disease
EnvironmentAdmission via ED or through transferIsolationNo clockNo daylightNo visitorsNoisePhysical restraints
Predisposing DiseaseCardiac diseaseCognitive impairment (eg, dementia)Pulmonary disease
Acute IllnessLength of stayFeverMedicine service Lack of nutritionHypotensionSepsisMetabolic disorders Tubes/cathetersMedications:- Anticholinergics- Corticosteroids- Benzodiazepines
Less Modifiable
More 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.
Mechanisms for Delirium in the Critically Ill Are 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)
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.
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
Worse Long-term Cognitive Performance
• 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
• Patient testimony“One quite literally loses one’s grip on what is true and what is false because the true and the false are mixed together in a mess of experience.”
Girard TD, et al. Crit Care Med. 2010;38:1513-1520.Misak CJ. Am J Respir Crit Care Med. 2004;170(4):357-359.
Risk Factors Specific for ICU Delirium
• Benzodiazepine use4,10
• Coma (medical vs. pharmacologic)4,9
• Morphine use (?data
unclear)
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 .
• Dementia1,2,3
• Hypertension history4,5
• Alcoholism3,4
• Severity of illness1,4,6,7,8
• Age (?pos6,8 /neg2,3,4,9)
Delirium After Stroke
Shi Q, et al. Stroke. 2012;43(3):645-649.
• Increased 12-month mortality risk • Stroke patients +/- delirium• Will delirium treatment change outcome?
Delirium Assessment Tools
• 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.
Confusion Assessment Method(CAM-ICU)
or3. Altered level of
consciousness4. 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
and
Intensive Care Delirium Screening Checklist
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
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
Pediatric CAM-ICU
Smith HA, et al. Crit Care Med. 2011;39(1):150-157.
146 paired assessments
Mean age = 12.2 years
2 critical care clinicians vs. pediatric psychiatrist
Sensitivity = 83% (95% CI, 66-93%)
Specificity = 99% (95% CI, 95-100%)
Inter-rater reliability κ = 0.96
Predicting Delirium in the ICUPRE-DELIRIC
• Development of model– 1613 ICU patients– Delirium defined as +CAM-ICU or haloperidol use– 10 variables
• Age • APACHE-II score• Admission group• Coma• Infection
• Validation of model– 549 ICU patients– Area under ROC
• PRE-DELIRIC 0.85
• Nurses 0.59
• Physicians 0.59
• Metabolic acidosis • Use of sedatives • Use of morphine• Urea concentration• Urgent admission
van den Boogaard M, et al. BMJ. 2012;344:e420.S
ensi
tivity
1 - Specificity
Pooled ROC
Delirium Assessment Implementation Strategies
• Case-based scenarios1 – Before-and-after case studies – This strategy increased usage of the ICDSC
by 70% and accuracy of assessment by 54% – http://www.biomedcentral.com/content/
supplementary/cc6793-S2.doc
• Spot-checking2,3 – Systematically uses expert raters – Identifies areas for fine tuning education
1. Devlin JW, et al. Crit Care. 2008;12(1):R19.2. Pun BT, et al. Crit Care Med. 2005;33(6):1199-1205.3. Soja SL, et al. Intensive Care Med. 2008;34(7):1263-1268.
Stop and THINK
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?
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
Delirium Nonpharmacologic Interventions
• Early mobility – the only nonpharmacologic intervention shown to reduce ICU delirium1
• Other interventions:– Environmental changes (eg, noise reduction)– Sensory aids (eg, hearing aids, glasses)– Reorientation and stimulation– Sleep preservation and enhancement
Schweickert WD, et al. Lancet. 2009;373:1874-1882.
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
Boosting Sleep Quality in ICU
• Optimize environmental strategies– Day/night variation, reduce night interruptions, noise reduction
• Avoid benzodiazepines (↓ 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
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.
Effect of Common Sedatives and Analgesics on Sleep
There is little evidence that administration of sedatives inthe 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
• AnalgesicsAbnormal sleep architecture
• Dexmedetomidine↑ SWS
Weinhouse GL, et al. Sleep. 2006;29:707-716.Nelson LE, et al. Anesthesiology. 2003;98:428-436.
Differences in BOLD activities/NREM sleep (fMRI)
Contribution of Sedative-Hypnotic Agents to Delirium Via Modulation of the Sleep Pathway
Sanders RD, Maze M. Can J Anesth. 2011;58:149-156.
A Multicomponent Intervention to Prevent Delirium in Hospitalized Older (Non-ICU) Patients
• 852 patients ≥ 70 years old on general medicine service, no delirium at time of admission
• Intervention – Standardized protocol for management of 6 delirium
risk factors (n = 426)
• Usual care – Standard hospital services (n = 426)
• Primary Outcome – Delirium incidence and prevalence
Inouye SK, et al. N Engl J Med. 1999;340:669-676.
Elder Life Program
Targeted Risk Factor Standardized Intervention
Cognitive impairmentOrientation & therapeutic activity protocol(discuss current events, word games, reorient, etc)
Sleep deprivationSleep enhancement & nonpharm sleep protocol(noise reduction, back massages, schedule adjustment)
ImmobilityEarly mobilization protocol(active ROM, reduce restraint use, ambulation, remove catheters)
Visual impairmentVision protocol(glasses, adaptive equipment, reinforce use)
Hearing impairmentHearing protocol(amplification devices, hearing aids, earwax disimpaction)
DehydrationDehydration protocol(early recognition of dehydration & volume repletion)
Inouye SK, et al. N Engl J Med. 1999;340:669-676.
Results
Outcome Intervention Control P-value
Incidence of delirium, N (%) 42 (9.9) 64 (15) 0.02
Total days of delirium 105 161 0.02
Episodes of delirium 62 90 0.03
• ↓ 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.
Survey: First-Choice Delirium Treatment Options
0
10
20
30
40
50
60
70
80
90
Haloperidol AtypicalAntipsychotic
Benzodiazepine Dexmedetomidine
%
• Delirium should always be managed with a medication: 85%• Use ≥ 2 medications to treat delirium: 68%
Characteristics of Haloperidol Use (always or frequently)
• Oral: 23%; IV 93%• As needed: 93%; Scheduled: 61%; Infusion: 0%• ≤ 4 mg/d: 47%; 5-10 mg/d: 56%; 11-20 mg/d: 38%;
≥ 21 mg/d: 9%
Devlin JW, et al. Ann Pharmacother. 2011;45(10):1217-1229.
Halope
ridol
Atypica
l
Antips
ycho
tic
Benzo
diaze
pine
Dexm
edet
omidi
ne
Dopamine Antagonist Haloperidol
• Adverse CV effects include QT interval prolongation
• Extrapyramidal symptoms, neuroleptic malignant syndrome (rare)1
• Does not cause respiratory depression1
• Dysphoria2• Hypnotic agent with antipsychotic properties1
Adverse EffectsClinical 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 adults1
• Metabolism altered by drug-drug interactions2
But…Use of Haloperidol Is an Independent Predictor for Prolonged Delirium
Pisani MA, et al. Crit Care Med. 2009;37:177-183.
Atypical Antipsychotics
• 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
Devlin JW, et al. Harv Rev Psychiatry. 2011;19:59-67.
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
Atypic
al
Antipsy
chotic
sBen
zodia
zepin
es
Haloper
idol
Propofo
l
2001
2007
Res
po
nd
ents
, %
The MIND Study
• Modifying the INcidence of Delirium (MIND)• Randomized and double-blind• Multisite (6 centers)• 103 MV patients• PO/IM delivery of study drug• Doses
– Haloperidol 5-20 mg – Ziprasidone 40-160 mg
Haloperidol Ziprasidone Placebo
Girard TD, et al. Crit Care Med. 2010;38(2):428-437.
n = 35 n = 32 n = 36
MIND Study Results
Outcome*Haloperidol
(n = 35)Ziprasidone
(n = 32)Placebo(n = 36) P
Delirium/coma-free days 14 [6-18] 15 [9-18] 13 [2-17] 0.65
Ventilator-free days 8 [0-15] 12 [0-19] 12 [0-23] 0.33
Length of stay
ICU 12 [5-16] 10 [4-15] 8 [5-13] 0.70
Hospital 14 [10-NA†] 14 [10-NA†] 16 [9-NA†] 0.67
Mortality, % 11 12 17 0.80
Extrapyramidal side effects
Daily EPS score 0 [0-0.2] 0 [0-0] 0 [0-0] 0.56
Cognition at discharge
Mean T-score 27 [25-31] 28 [24-35] 33 [23-36] 0.50
*Median [interquartile range] except as noted
Girard TD, et al. Crit Care Med. 2010;38(2):428-437.
Prophylactic Haloperidol
• 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
Wang W, et al. Crit Care Med. 2012;40(3):731-739.
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 (%) 15.3 23.2 0.031
Mean time to delirium onset (days) 6.2 5.7 0.021
Mean time delirium-free (days) 6.8 6.7 0.027
Median ICU LOS (hours) 21.3 23.0 0.024
All-cause 28-day mortality (%) 0.9 2.6 0.175
Quetiapine vs. Placebo
• 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 (n = 18) Placebo (n = 18)
Delirium + Haloperidol PRN
Devlin JW, et al. Crit Care Med. 2010;38(2):419-427.
TIME TO DELIRIUM RESOLUTION
Surv
ival
Dis
trib
utio
n Fu
nctio
n
0.00
0.25
0.50
0.75
1.00
daydelre
0 2 4 6 8 10
STRATA: DSMBassig=1Censored DSMBassig=1DSMBassig=2
Placebo
Quetiapine
Pro
po
rtio
n o
f P
atie
nts
wit
h D
elir
ium
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
Impact of Quetiapine on the Resolution of Individual Delirium Symptoms
Median ICDSC and individual delirium symptoms similar at study baseline
Quetiapine Placebo P value
Median time to symptom resolution Log rank
Inattention 3 hrs 8 hrs 0.10
Disorientation 2 hrs 10 hrs 0.10
Symptom fluctuation
4 hrs 14 hrs 0.004
Agitation 5 hrs 1 hrs 0.04Time with each symptom [median (IQR)] Comparison of
Proportions
Inattention 47 (0-67)% 78 (43-100)% 0.02
Hallucinations 0 (0-17)% 28 (0-43)% 0.10
Symptom fluctuation
47 (19-67)% 89 (33-100)% 0.04
Devlin JW, et al. Crit Care. 2011;15(5):R215.
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)
Su
rviv
al (
%)
Impact of Pain-Sedation-Delirium Protocol on Subsyndromal Delirium
Duration of MV ICU LOS Hospital LOS0
10
20
30
40
50
60
5.9 5.3
27
7.5 6.3
55Protocol n = 561
PRE protocol n = 572
Mea
n T
ime
(day
s)
P = 0.009
P < 0.001
P = 0.01
Significant Patient Characteristics/Metrics/Outcomes
Protocol PRE P-value
Delirium† (34.2) (34.7) 0.9
Subsyndromal Delirium†
(24.6) (33) 0.009
Lorazepam equivalents, mg*
2.75 ± 7.94
5.79 ± 31.78
0.02
MSO4 equivalents, mg*
22.3 ± 40.1
103.5 ± 239.2
< 0.001
*Data presented in mean; †Data presented as n (%)Subsyndromal delirium; max ICDSC 1-2 in ICU
Skrobik Y, et al. Anesth Analg. 2010;111(2):451-463.
Before Considering a Pharmacologic Treatment for Delirium…
• 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?
Inouye SK, et al. N Engl J Med. 1999;340:669-676.
Antipsychotics. http://www.canhr.org/ToxicGuide/Media/Articles/FDA%20Alert%20on%20Antipsychotics.pdf. Accessed March 2012.
Antipsychotic TherapyRule 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
AwakeningBreathingCoordination/Choice of SedationDelirium Monitoring and ManagementEarly Mobilization
ABCDE
Early MobilizationPatient 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 Enrolment in another trial
Schweickert WD, et al. Lancet. 2009;373:1874-1882.
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.
Perform Safety Screen First• Patient responds to verbal stimulation (ie, RASS -3)*• FIO2 ≤ 0.6
• PEEP ≤ 10 cmH2O
• No dose of any vasopressor infusion for at least 2 hours• No evidence of active myocardial ischemia (24 hrs)• No arrhythmia requiring the administration of new
antiarrhythmic agent (24 hrs)
Schweickert WD, et al. Lancet. 2009;373:1874-1882.
Pass Fail
Exercise/Mobility Therapy
Too Ill for Exercise/Mobility
*Range of motion may be
started in comatose patients,
but not considered Early
Exercise/Mobility
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)
Early PT and OT in Mechanically Ventilated ICU Patients
Duration of ICU Delirium
Mechanical Venti-lation
ICU LOS Hospital LOS0
2
4
6
8
10
12
14
16
23.4
5.9
13.5
4
6.1
7.9
12.9
PT/OT with DSI n = 49DSI alone n = 55
Me
dia
n T
ime
(d
ay
s)
Schweickert WD, et al. Lancet. 2009;373(9678):1874-1882.
P = 0.02
P = 0.08
P = 0.02
P = 0.93All Patients
Protocol for Early Mobility TherapyAcute Respiratory Failure Patients
Morris PE, et al. Crit Care Med. 2008;36(8):2238-2243.
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 11.3 5.0 0.001
Ventilator days 10.2 8.8 0.163
ICU LOS days 6.9 5.5 0.025
Hospital LOS days 14.5 11.2 0.006
Primary Endpoint: more protocol patients received PT than did usual care (80% vs. 47%, P ≤ 0.001)
*Values adjusted for BMI, Acute Physiology and Chronic Health Evaluation II, and vasopressors
Early Mobility Resources• Agency for Healthcare Research and Quality (AHRQ) website has a description of
LDS Hospital’s (Salt Lake City, UT) Early Mobility Program implementation process. Helpful points on how to get started:
– http://www.innovations.ahrq.gov/content.aspx?id=2442
• Overview of the implementation of a Early Mobility Quality Improvement Program in the ICUs at Johns Hopkins University in Baltimore, MD
– Needham DM, Korupolu R. Rehabilitation Quality Improvement in an Intensive Care Unit Setting: Implementation of a Quality Improvement Model. Top Stroke Rehabil. 2010;17(4):271-281.
• This video highlights the patient’s perspective; watch the patient ambulating in the ICU while mechanically ventilated
– http://www.youtube.com/watch?v=0jycOFVE624 (Full version: 9 minutes)
– http://www.youtube.com/watch?feature=player_detailpage&v=aobZTnhMK1g (Shorter version: 2 minutes)
• Dale Needham, MD, PhD, talks about the Early Mobility Program at Johns Hopkins University (2.5 minutes)
– http://www.youtube.com/watch?v=D53gygWRhLM
Ely EW, et al. N Engl J Med. 1996;335(25):1864-1869.
Kress JP, et al. N Engl J Med. 2000;342(20):1471-1477.
Girard TD, et al. Lancet. 2008;371(9607):126-134.
Strøm T, et al. Lancet. 2010;375(9713):475-480.
Pandharipande PP, et al. JAMA. 2007;298(22):2644-2653.
Riker RR, et al. JAMA. 2009;301(5):489-499.
Schweickert WD, et al. Lancet. 2009;373(9678):1874-1882.
Liberation and AnimationSummary of RCT Literature
SBT
SAT
Remove (A+B)
Remove Sedation
Sedation Choice
Sedation Choice
Early Mobility
Post-Intensive Care Syndrome
• 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.”
Needham DM, et al. Crit Care Med. 2012;40(2):502-509.
Post Intensive Care Syndrome (PICS)
Family(PICS-F)
Mental HealthAnxiety/ASD
PTSDDepression
Complicated Grief
Survivor(PICS)
Mental HealthAnxiety/
ASDPTSD
Depression
Cognitive
ImpairmentsExecutiv
e FunctionMemoryAttention
Physical
ImpairmentsPulmona
ryNeuromuscularPhysical 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
PICS Checklist: Have We….
• Limited sedation? • Changed goals from "arouseable" to "cognitively engaged“• Promoted early physical and cognitive activity to engage the
brain?• Treated pain first and used benzodiazepines only when
necessary?• Limited drugs that block memory (exception: AWS)?• Assessed and treated pts with alcohol dependency? • Encouraged family involvement (for both the health of the pt
and the family)?• Performed a thorough medication reconciliation?
• Communicated with the pt and family to support psychological well-being?
• Offered pt care conferences when indicated?• Translated/interpreted when indicated?• Maintained glycemic control without causing hypoglycemia?• Encouraged uninterrupted sleep at night and for at least 2 hours in the
afternoon?• Assured that the pt who has dentures and glasses wears them when
conscious?• Assessed for delirium? • Noted the presence of delirium in the progress notes for coding and
communication?• Considered maintaining a pt diary of key events to share with the
family?
PICS Checklist: Have We….
PICS Hand-Off Checklist
• Have we coordinated care prior to transfer?– Referred cognitive issues to speech therapy/OT (taught pt/family
cognitive recovery exercises)– Referred psychiatric issues to psych consult (taught pt/family
coping strategies)– Referred physical issues to PT (promoting physical activity that
engages the brain)– Discussed with family lasting effects of illness and the possible
need for continued care (assured them that this is common, and will take time to resolve)
– Recorded current physical, cognitive and psychological issues, informed next provider?
How to Identify Barriers
• The ABCDE Bundle focuses on aligning and supporting:– People– Processes– Technology
• These are three key areas to evaluate when identifying barriers to adoption and implementation
People: Who Is on Your Team?
• Nurses• Doctors• Pharmacists• Respiratory therapists• PT/OT• Administration
Processes:What Does Your Team Have in Place?
• What do you do well? (ABCDEs)• Where do you need help?• What is in motion?• What has not started?
What Is the Role of Technology?
• Computerized charting• Computerized order entry• Keep it simple• Size of the institution• Measure outcomes
• Tendency to maintain the status quo• Resistance of independent groups to alter their
behaviors and relinquish some autonomy• Perceived disproportionality of outcomes from the
proposed change to the efforts required for change• Lack of significant prioritization• Insufficient personal accountability for completing
change • Inadequate knowledge about clinical outcomes
General Barriers to Changing the ICU Culture
Hatler CW, et al. Am J Crit Care. 2006;15:549-555.
Nursing-Implemented Sedation Protocol: Barnes Jewish Pilot United States
2.3
5.7
14
4.8
7.5
20
0
5
10
15
20
25
Duration of MV ICU LOS Hospital LOS
Me
dia
n T
ime
(d
ay
s)
Protocol n = 162
Routine n = 159
P = 0.13
P < 0.001
P = 0.003
Significant patient characteristics/metrics/outcomes
Protocol Routine P value
CIVS† 66 (40) 66 (42) 0.9
Duration CIVS, hrs* 3.5 ± 4 5.6 ± 6.4 0.003
Bolus† 118 (72) 127 (80) 0.14
Reintubated† 14 (8.6) 21 (13) 0.2
Trached† 10 (6.2) 21 (13.2) 0.04
*Data presented in median; †Data presented as n (%)CIVS: continuous intravenous infusion sedation
Brook AD, et al. Crit Care Med. 1999;27(12):2609-2615.
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 Ramsay with bolus requirements before initiation of continuous infusion and uptitration of opioids and benzodiazepines.
Nursing-Implemented Sedation Protocol: Bocage University Hospital France
4.25
17
8
11
21
0
5
10
15
20
25
Duration of MV ICU LOS Hospital LOS
Me
dia
n T
ime
(d
ay
s)
Protocol n = 197
Control n = 226
P = 0.004
P = 0.003
P = 0.001
Significant patient characteristics/metrics/outcomes
Protocol Control P value
Daily midazolam, mg*
44 ± 31 92 ± 59 0.001
Duration midazolam, hrs**
3 5 0.18
Reintubated† 11 (6) 29 (13) 0.01
VAP diagnosis† 12 (6) 34 (15) 0.005
*Data presented in mean; ** Data presented in median†Data presented as n (%)
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.
Pharmacist Enforced Adherence to an ICU Sedation Guideline: Boston Medical Center MICU
5.3
7
11.8
8.9
10.6
19.8
0
5
10
15
20
25
Duration of MV ICU LOS Hospital LOS
Me
dia
n T
ime
(d
ay
s)
RPh intervention n = 78
Control n = 78
P = 0.002
P = 0.001
P = 0.0004
Significant patient characteristics/metrics/outcomes
RPh Control P value
Alcohol/drug overdose†
15 (19.2) 6 (7.7) 0.03
Lorazepam equivalents/vent day, mg*
65.2 ± 114.1
74.8 ± 76.1
0.54
Fentanyl equivalents/vent day, mcg*
102.5 ± 328
400 ± 1026
0.02
*Data presented in mean ; †Data presented as n (%)
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.
Quality Improvement Project: Implementing ABCDE
• 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
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.
QI Program for Changing the ICU Culture
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Summarize the Evidence
Identify Local Barriers to Implementation
Measure Performance
Ensure All Patients Receive the Interventions
Barriers to Changing the ICU Culture (cont)
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Developing and Implementing ICU Sedation Protocols and Guidelines
Phase I:
Development
Phase II:
Implementation
Phase III:
Continuous Quality Improvement (CQI)
1. Creation of the “physical champion(s)”
2. Multidisciplinary Committee
3. Data synthesis
4. Protocol drafting
1. Periodic Metric Assessment
2. Guideline update with current literature
3. Publication of efficacy, safety, and compliance data
• Benchmarking against other institutions
• Assistance in guideline development
1. Pilot Analysis• Efficacy, Safety,
Adherence
2. Endorsement of protocol from institutional credible bodies
3. Education to all ICU clinicians
4. Integration with electronic documentation and clinical monitoring systems
Key Steps for Effective Change
Wheelan SA, et al. Am J Crit Care. 2003;12:527-534.Durbin CG. Crit Care Med. 2006;34(3 Suppl):S12-S17.
• Linking effective care processes with hospital and long-term patient outcomes
• Creating a strategy to improve teamwork and collaboration
• Creating a process for early mobilization • Recognizing that current practice patterns may
interfere with mobility • Agreeing on a need to change • Identification of a local champion
Conclusions
• Oversedation in the ICU is common; associated with negative sequelae
• Analgosedation has been shown to improve outcomes; consider sedation only if necessary
• Use 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
• 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
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