Awakening and Breathing (AB) - SEDATION

Report
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
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.
Wong DL, et al. Wong’s Essentials of Pediatric Nursing. 6th ed.
St. Louis, MO: Mosby, Inc; 2001. p.1301.
Managing Pain in the ICU: Opioids
Clinical Effects
Adverse Effects
• Respiratory depression
• Analgesia
• Sedation
• Hypotension
• Bradycardia
• Constipation
• Tolerance
Fentanyl
• Withdrawal symptoms
• Hormonal changes
Morphine
Remifentanil
Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S105-120.
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.
ABCDE
Awakening
Breathing
Coordination/Choice of Sedation
Delirium Monitoring and Management
Early Mobilization
ICU Sedation: The Balancing Act
Patient Comfort
and Ventilatory Optimization
Oversedation
Undersedation
• Patient recall
• Device removal
• Ineffectual mechanical ventilation
• Initiation of neuromuscular blockade
• Myocardial or cerebral ischemia
• Decreased family satisfaction w/ care
Jacobi J, et al. Crit Care Med. 2002;30:119-141.
G
O
A
L
• Prolonged mechanical ventilation
• Increase length of stay
• Increased risk of complications
- Ventilator-associated pneumonia
• Increased diagnostic testing
• Inability to evaluate for delirium
Improper Sedation
30.6%
•
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
15.4%
– $31,574 versus $12,931, P < 0.001
54.0%
•
Sedation should be titrated to achieve a
cooperative patient and daily wake-up,
a JC requirement1,2
Undersedated3
Oversedated
On Target
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.
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
Post implemenation n = 130
80
Incidence of pain or agitation (%)
P < 0.01
70
Significant Patient
Characteristics/Metrics/Outcomes
Control n = 100
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
17 (17)
11 (8)
< 0.05
63
60
50
42
P < 0.01
40
29
30
20
12
10
0
Pain
Agitation
Chanques G, et al. Crit Care Med. 2006;34(6):1691-1699.
Nosocomial
infection†
*Data presented in median hrs; †Data presented as n (%)
CIVS; Continuous intravenous infusion sedation
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.
ABC Trial: Objectives
• 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
Girard TD, et al. Lancet. 2008;371:126-134.
ABC Trial: Main Outcomes
Outcome*
SBT
SAT+SBT
P-value
12
15
0.02
Successful extubation, days
7.0
5
0.05
ICU discharge, days
13
9
0.02
Hospital discharge, days
19
15
0.04
97 (58%)
74 (44%)
0.01
Coma
3.0
2.0
0.002
Delirium
2.0
2.0
0.50
Ventilator-free days
Time-to-Event, days
Death at 1 year, n (%)
Days of brain dysfunction
*Median, except as noted
Girard TD, et al. Lancet. 2008;371:126-134.
ABC Trial: 1 Year Mortality
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.
Barriers to Daily Sedation Interruption
(Survey of 904 SCCM members)
Increased device removal
Poor nursing acceptance
Compromises patient comfort
Leads to respiratory compromise
Difficult to coordinate with nurse
No benefit
#1 Barrier
Leads to cardiac ischemia
#2 Barrier
Leads to PTSD
#3 Barrier
0
10
20
30
40
50
60
70
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.
Awakening and Breathing (AB)
Safety Screens
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•
•
•
•
•
Awakening Trial
No active seizures
No active alcohol withdrawal
No active agitation
No active paralytic use
No myocardial ischemia (24h)
Normal intracranial pressure
Girard TD, et al. Lancet. 2008;371(9607):126-134.
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
ABCDE
Awakening
Breathing
Coordination/Choice of Sedation
Delirium Monitoring and Management
Early Mobilization
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
•
•
•
•
•
•
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Chronic pain
Organ dysfunction
CV instability
Substance withdrawal
Respiratory insufficiency
Obesity
Obstructive sleep apnea
GABA Agonist
Benzodiazepine Midazolam
Clinical Effects
• Sedation, anxiolysis, and
amnesia
• Rapid onset of action (IV)
Adverse Effects
• May accumulate with hepatic
and/or renal failure
• Anterograde amnesia
• Long recovery time
• Synergy with opioids
• Respiratory depression
• Delirium
Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360.
Riker RR, et al; SEDCOM Study Group. JAMA. 2009;301(5):489-499.
GABA Agonist
Benzodiazepine Lorazepam
Clinical Effects
• Sedation, anxiolysis, and
amnesia
• Commonly used for longterm sedation
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.
GABA Agonist Propofol
Clinical Effects
Adverse Effects
• Sedation
• Pain on injection
• Hypnosis
• Respiratory depression
• Anxiolysis
• Hypotension
• Muscle relaxation
• Decreased myocardial contractility
• Mild bronchodilation
• Increased serum triglycerides
• Decreased ICP
• Tolerance
• Decreased cerebral metabolic rate
• Propofol infusion syndrome
• Antiemetic
• Prolonged effect with high adiposity
• Seizures (rare)
Ellett ML. Gastroenterol Nurs. 2010;33(4):284-925.
Lundström S, et al. J Pain Symptom Manage. 2010;40(3):466-470.
a2 Agonist Clonidine
Clinical Effects
•
•
•
•
•
Antihypertensive
Analgesia
Sedation
Decrease sympathetic activity
Decreased shivering
Adverse Effects
•
•
•
•
Bradycardia
Dry mouth
Hypotension
Sedation
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
Clinical Effects
•
•
•
•
•
•
•
Antihypertensive
Sedation
Analgesia
Decreased shivering
Anxiolysis
Patient arousability
Potentiate effects of opioids,
sedatives, and anesthetics
• Decrease sympathetic activity
Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349.
Bhana N, et al. Drugs. 2000;59(2):263-268.
Adverse Effects
•
•
•
•
•
•
Hypotension
Hypertension
Nausea
Bradycardia
Dry mouth
Peripheral vasoconstriction at
high doses
Comparison of Clinical Effects
Benzodiazepines Propofol
Sedation
X
Alleviate anxiety1,2
X
X
Opioids
a2 Agonists
Haloperidol
X
X
X
X
Analgesic properties1-4
X
X
Promote arousability
during sedation2-4
Facilitate ventilation
during weaning2-4
X
X
Control delirium1-4
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.
X
X
X
Comparison of Adverse Effects
Benzodiazepines
Propofol
Opioids
Prolonged weaning 1
X
X
X*
Respiratory depression 1
X
X
X
Hypotension 1-3
X
X
X
Constipation 1
Deliriogenic
Haloperidol
X
X
X
X
X
X
X
Tachycardia 1
Bradycardia 1
a2 Agonists
X
morphine
X
fentanyl
*Excluding remifentanil
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.
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
P = 0.086
P < 0.001
•
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
6
2
4
Days
8
10
12
P = 0.011
0
Dexmedetomidine n = 52
Delirium/Coma-Free
Days
Delirium-Free
Days
Coma-Free
Days
Pandharipande PP, et al. JAMA. 2007;298:2644-2653.
Lorazepam n = 51
MENDS Delirium: All Patients
Pandharipande PP, et al. Crit Care. 2010;14:R38.
SEDCOM:
Dexmedetomidine vs Midazolam
• 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
Outcome
PMidazolam Dexmedetomidine
Value
(n = 122)
(n = 244)
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
93 (76.6%)
132 (54%)
0.001
1.7
2.5
0.002
60 (49%)
153 (63%)
0.02
Delirium prevalence
Delirium-free days
Patients receiving open-label midazolam
Riker RR, et al. JAMA. 2009;301:489-499.
Reduced Delirium Prevalence with
Dexmedetomidine vs Midazolam
SEDCOM
Patients With Delirium, %
100
Dexmedetomidine versus Midazolam, P < 0.001
80
Midazolam
60
Dexmedetomidine
40
20
0
Baseline
1
2
3
4
5
6
57 92
42 60
44 34
Treatment Day
Sample Size
118 229
109 206
Riker RR, et al. JAMA. 2009;301:489-499.
92 175
77 134
SEDCOM Trial:
Safety Outcomes
Outcome
Midazolam
(n = 122)
Dexmedetomidine P(n = 244)
Value
Bradycardia
Bradycardia needing treatment
18.9%
0.8%
42.2%
4.9%
0.001
0.07
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.
MIDEX and PRODEX Trials
MIDEX
PRODEX
•
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)
Hypo
tension
Brady
cardia
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
Propofol
64.7%
118
185
40.1
13.4%
10.1%
Dex
64.6%
97
164
51.3
13.0%
13%
0.97
0.24
P-value
Jakob SM, et al. JAMA. 2012;307(11):1151-1160.
< 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.
Analgosedation
Results
• 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.
ABCDE
Awakening
Breathing
Coordination/Choice of Sedation
Delirium Monitoring and Management
Early Mobilization
Cardinal Symptoms of Delirium and Coma
Morandi A, et al. Intensive Care Med. 2008;34:1907-1915.
ICU Delirium
• 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
Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233.
Patient Factors
Predisposing Disease
Increased age
Alcohol use
Male gender
Living alone
Smoking
Renal disease
Cardiac disease
Cognitive impairment
(eg, dementia)
Pulmonary disease
Less
Modifiable
Acute Illness
DELIRIUM
Environment
Admission via ED or
through transfer
Isolation
No clock
No daylight
No visitors
Noise
Physical restraints
More
Modifiable
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.
Length of stay
Fever
Medicine service
Lack of nutrition
Hypotension
Sepsis
Metabolic disorders
Tubes/catheters
Medications:
- Anticholinergics
- Corticosteroids
- Benzodiazepines
Mechanisms for Delirium in the Critically Ill Are
Numerous and Not Clearly Understood
• 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)
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)
Sequelae of Delirium
During the
ICU/Hospital Stay
After Hospital
Discharge
• 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
Kaplan-Meier Survival Curve
P < 0.001
Each day of delirium in the ICU increases the hazard of mortality by 10%
Pisani MA. Am J Respir Crit Care Med. 2009;180:1092-1097.
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
•
•
•
•
•
Dementia1,2,3
Hypertension history4,5
Alcoholism3,4
Severity of illness1,4,6,7,8
Age (?pos6,8 /neg2,3,4,9)
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 .
• Benzodiazepine
use4,10
• Coma (medical vs.
pharmacologic)4,9
• Morphine use (?data
unclear)
Delirium After Stroke
• Increased 12-month mortality risk
• Stroke patients +/- delirium
• Will delirium treatment change outcome?
Shi Q, et al. Stroke. 2012;43(3):645-649.
Delirium Assessment Tools
• Confusion Assessment Method for the ICU (CAMICU)
– 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)
1. Acute onset of mental status
changes or a fluctuating course
and
2. Inattention
and
3. Altered level of
consciousness
or
= Delirium
Ely EW, et al. Crit Care Med. 2001;29:1370-1379.
Ely EW, et al. JAMA. 2001;286:2703-2710.
4. Disorganized
thinking
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
Score 1 point for each component present during shift
• Score of 1-3 = Subsyndromal Delirium
• Score of ≥ 4 = Delirium
Bergeron N, et al. Intensive Care Med. 2001;27:859-864.
Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013.
Pediatric CAM-ICU
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
Smith HA, et al. Crit Care Med. 2011;39(1):150-157.
Predicting Delirium in the ICU
PRE-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
Metabolic acidosis
Use of sedatives
Use of morphine
Urea concentration
Urgent admission
Sensitivity
• Validation of model
Pooled ROC
– 549 ICU patients
– Area under ROC
• PRE-DELIRIC
0.85
• Nurses
0.59
• Physicians
0.59
van den Boogaard M, et al. BMJ. 2012;344:e420.
1 - Specificity
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/supple
mentary/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.
Helpful Approach to
Delirium Management
1. Stop
2. THINK
3. Lastly medicate
Stop and THINK
Do any meds need to be
stopped or lowered?
• Especially consider
sedatives
Toxic Situations
• Is patient on minimal
amount necessary?
Hypoxemia
Infection/sepsis (nosocomial)
Immobilization
Nonpharm interventions
– Daily sedation cessation
– Targeted sedation plan
• Do sedatives need to be
changed?
• CHF, shock, dehydration
• Deliriogenic meds (tight titration)
• New organ failure (liver/kidney)
• 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
There is little evidence that
sedatives in the ICU restore
normal sleep
Friese R. Crit Care Med. 2008;36:697-705.
Weinhouse GL, Watson PL. Crit Care Clin. 2009;25:539-549.
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 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
Weinhouse GL, et al. Sleep. 2006;29:707-716.
Nelson LE, et al. Anesthesiology. 2003;98:428-436.
Contribution of Sedative-Hypnotic Agents to
Delirium Via Modulation of the Sleep Pathway
Differences in BOLD activities/NREM sleep (fMRI)
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 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)
Inouye SK, et al. N Engl J Med. 1999;340:669-676.
Results
Outcome
Intervention
Control
P-value
42 (9.9)
64 (15)
0.02
Total days of delirium
105
161
0.02
Episodes of delirium
62
90
0.03
Incidence of delirium, N (%)
•
•
•
•
↓ 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
• Delirium should always be managed with a medication: 85%
• Use ≥ 2 medications to treat delirium: 68%
90
Characteristics of Haloperidol Use
(always or frequently)
80
70
• 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%
60
%
50
40
30
20
10
0
Haloperidol
Atypical
Antipsychotic
Benzodiazepine
Devlin JW, et al. Ann Pharmacother. 2011;45(10):1217-1229.
Dexmedetomidine
Dopamine Antagonist Haloperidol
Clinical Effects
• Hypnotic agent with antipsychotic
properties1
– For treatment of delirium in
critically ill adults1
• Does not cause respiratory
depression1
Adverse Effects
• Dysphoria2
• Adverse CV effects include QT
interval prolongation
• Extrapyramidal symptoms,
neuroleptic malignant syndrome
(rare)1
• Metabolism altered by drug-drug
interactions2
1. Harvey MA. Am J Crit Care. 1996;5:7-16.
2. Crippen DW. Crit Care Clin. 1990;6:369-392.
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
90
Respondents, %
80
70
60
2001
50
2007
40
30
20
10
0
Ely EW, et al. Crit Care Med. 2004;32:106-112.
Patel RP, et al. Crit Care Med. 2009;37:825-832.
The MIND Study
Haloperidol
Ziprasidone
n = 35
•
•
•
•
•
•
Placebo
n = 32
Modifying the INcidence of Delirium (MIND)
Randomized and double-blind
Multisite (6 centers)
103 MV patients
PO/IM delivery of study drug
Doses
– Haloperidol
– Ziprasidone
5-20 mg
40-160 mg
Girard TD, et al. Crit Care Med. 2010;38(2):428-437.
n = 36
MIND Study Results
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
12 [5-16]
10 [4-15]
8 [5-13]
0.70
14 [10-NA†]
14 [10-NA†]
16 [9-NA†]
0.67
11
12
17
0.80
0 [0-0.2]
0 [0-0]
0 [0-0]
0.56
27 [25-31]
28 [24-35]
33 [23-36]
0.50
Outcome*
Length of stay
ICU
Hospital
Mortality, %
Extrapyramidal side effects
Daily EPS score
Cognition at discharge
Mean T-score
*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
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
Wang W, et al. Crit Care Med. 2012;40(3):731-739.
Quetiapine vs. Placebo
Delirium +
Haloperidol PRN
Quetiapine (n = 18)
•
•
•
•
•
•
Placebo (n = 18)
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)
Devlin JW, et al. Crit Care Med. 2010;38(2):419-427.
Proportion of Patients with Delirium
Patients with First Resolution of Delirium
Log-Rank
P = 0.001
Placebo
Quetiapine
Day During Study Drug Administration
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.
Impact of Quetiapine on the Resolution of
Individual Delirium Symptoms
Median ICDSC and individual delirium symptoms similar at study baseline
Quetiapine
Placebo
Median time to symptom resolution
P value
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
0.04
Time 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
47 (19-67)%
89 (33-100)%
0.04
Symptom
fluctuation
Devlin JW, et al. Crit Care. 2011;15(5):R215.
Rivastigmine for Delirium?
Survival (%)
• 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:
Time (days after inclusion)
− Need RCTs for delirium as endpoint
− Don’t use rivastigmine for ICU delirium
http://www.accessdata.fda.gov. Accessed March 2012.
Van Eijk MM, et al. Lancet . 2010;376(9755):1829-1837.
Impact of Pain-Sedation-Delirium Protocol
on Subsyndromal Delirium
60
Significant Patient Characteristics/Metrics/Outcomes
Protocol n = 561
55
PRE protocol n = 572
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
Mean Time (days)
50
40
P < 0.001
30
20
10
27
P = 0.01
5.9
7.5
P = 0.009
5.3 6.3
0
Duration of MV
ICU LOS
Hospital LOS
Skrobik Y, et al. Anesth Analg. 2010;111(2):451-463.
*Data presented in mean; †Data presented as n (%)
Subsyndromal delirium; max ICDSC 1-2 in ICU
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.
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
Antipsychotics. http://www.canhr.org/ToxicGuide/Media/Articles/FDA%20Alert%20on%20Antipsychotics.pdf.
Accessed March 2012.
ABCDE
Awakening
Breathing
Coordination/Choice of Sedation
Delirium Monitoring and Management
Early Mobilization
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
 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)
*Range of motion may be
Pass
Exercise/Mobility
Therapy
Schweickert WD, et al. Lancet. 2009;373:1874-1882.
Fail
Too Ill for
Exercise/Mobility
started in comatose patients,
but not considered Early
Exercise/Mobility
Early Mobilization Protocol: Result
• Return to independent functional status at discharge
– 59% in intervention group
– 35% in control group (P = 0.02)
Schweickert WD, et al. Lancet. 2009;373:1874-1882.
Early PT and OT in
Mechanically Ventilated ICU Patients
All Patients
16
14
Median Time (days)
P = 0.93
PT/OT with DSI n = 49
DSI alone n = 55
13.5
12
P = 0.08
10
8
P = 0.02
7.9
P = 0.02
6.1
6
4
4
2
12.9
5.9
3.4
2
0
Duration of ICU
Delirium
Mechanical
Ventilation
Schweickert WD, et al. Lancet. 2009;373(9678):1874-1882.
ICU LOS
Hospital LOS
Protocol for Early Mobility Therapy
Acute Respiratory Failure Patients
Morris PE, et al. Crit Care Med. 2008;36(8):2238-2243.
Early Mobility Therapy Results
Primary Endpoint: more protocol patients received PT
than did usual care (80% vs. 47%, P ≤ 0.001)
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
*Values adjusted for BMI, Acute Physiology and Chronic
Health Evaluation II, and vasopressors
Morris PE, et al. Crit Care Med. 2008;36(8):2238-2243.
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
Benefits of ABCDE Protocol
Morandi A, et al. Curr Opin Crit Care. 2011;17:43-49.
Liberation and Animation
Summary of RCT Literature
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.
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.
PICS Consequences
Post Intensive
Care Syndrome
(PICS)
Family
(PICS-F)
Mental Health
Anxiety/ASD
PTSD
Depression
Complicated Grief
Survivor
(PICS)
Mental
Health
Cognitive
Impairments
Anxiety/ASD
PTSD
Depression
Executive
Function
Memory
Attention
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.
Physical
Impairments
Pulmonary
Neuromuscular
Physical Function
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?
PICS Checklist: Have We….
• Communicated with the pt and family to support psychological wellbeing?
• 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 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?
Introducing ABCDE in the ICU:
Practical Advice for Implementing
Protocols
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
General Barriers to
Changing the ICU Culture
• 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
Hatler CW, et al. Am J Crit Care. 2006;15:549-555.
Nursing-Implemented Sedation Protocol:
Barnes Jewish Pilot United States
25
P < 0.001
Protocol n = 162
Routine n = 159
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
20
Median Time (days)
20
14
15
P = 0.13
10
P = 0.003
4.8
5
7.5
5.7
*Data presented in median; †Data presented as n (%)
CIVS: continuous intravenous infusion sedation
2.3
0
Duration of MV
ICU LOS
Hospital LOS
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.
Brook AD, et al. Crit Care Med. 1999;27(12):2609-2615.
Nursing-Implemented Sedation Protocol:
Bocage University Hospital France
25
Significant patient characteristics/metrics/outcomes
Protocol n = 197
Control n = 226
P = 0.003
21
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
Median Time (days)
20
17
P = 0.004
15
11
P = 0.001
10
5
8
4.2
*Data presented in mean; ** Data presented in median
†Data presented as n (%)
5
0
Duration of MV
ICU LOS
Hospital LOS
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
25
RPh intervention n = 78
P = 0.001
Significant patient characteristics/metrics/outcomes
Control n = 78
19.8
Median Time (days)
20
RPh
Control
P value
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
Alcohol/drug
overdose†
P = 0.002
15
P = 0.0004
11.8
10.6
8.9
10
7
5.3
*Data presented in mean ; †Data presented as n (%)
5
0
Duration of MV
ICU LOS
Hospital LOS
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
Summarize the Evidence
Identify Local Barriers to
Implementation
Measure Performance
Ensure All Patients
Receive the Interventions
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Barriers to Changing the ICU Culture
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Barriers to Changing
the ICU Culture (cont)
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Results of ICU Quality Initiative
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Results of ICU Quality Initiative (cont)
Needham DM, et al. Top Stroke Rehabil. 2010;17(4):271-281.
Developing and Implementing ICU
Sedation Protocols and Guidelines
Phase III:
Phase II:
Phase I:
Implementation
Continuous Quality
Improvement (CQI)
Development
1. Pilot Analysis
1. Creation of the “physical
champion(s)”
2. Multidisciplinary
Committee
3. Data synthesis
4. Protocol drafting
• 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
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
Key Steps for Effective Change
• 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
Wheelan SA, et al. Am J Crit Care. 2003;12:527-534.
Durbin CG. Crit Care Med. 2006;34(3 Suppl):S12-S17.
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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