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Evidence based ICU
1. Evidence Behind PAD 1
AHRQ Safety Program for Mechanically Ventilated Patients
Evidence Behind Pain, Agitation, and Delirium:
Assessments and Sedation Management
AHRQ Safety Program for
Mechanically Ventilated Patients
AHRQ Pub. No. 16(17)-0018-43-EF
January 2017
2. Evidence Behind PAD 2
AHRQ Safety Program for Mechanically Ventilated Patients
Learning Objectives
After this session, you will be able to—
• Identify the objectives and benefits of using the
ABCDEF bundle
• Understand evidence supporting the use of the
Society of Critical Care Medicine’s (SCCM) guidelines
for the management of Pain, Agitation, and Delirium
(PAD)
• Improve the care of mechanically ventilated patients
in the intensive care unit (ICU) through delirium
assessments and sedation management
3. Evidence Behind PAD 3
AHRQ Safety Program for Mechanically Ventilated Patients
Delirium
Pain, Agitation, and Delirium1
Pain, agitation, and
delirium in the ICU are
interrelated and add
another layer of
complexity when
providing care to
mechanically ventilated
patients.
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for
the management of pain, agitation, and delirium in adult patients in
the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306.
PMID: 23269131.
4. Evidence Behind PAD 4
AHRQ Safety Program for Mechanically Ventilated Patients
Pain, Agitation, and Delirium1
• The International Association for the Study of
Pain defines pain as an “unpleasant sensory
and emotional experience associated with
actual or potential tissue damage, or
described in terms of such damage.”
• The negative consequences of unrelieved pain
in ICU patients are significant and long lasting.
• Many critically ill patients may be unable to
self-report pain due to the use of mechanical
ventilation or high doses of sedative agents or
neuromuscular blocking agents.
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for
the management of pain, agitation, and delirium in adult patients in
the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306.
PMID: 23269131.
5. Evidence Behind PAD 5
AHRQ Safety Program for Mechanically Ventilated Patients
Pain, Agitation, and Delirium1
• Agitation and anxiety occur frequently in
critically ill patients and are associated with
adverse clinical outcomes
• Sedatives are commonly administered to ICU
patients to treat agitation and its negative
consequences
• Sedatives can be titrated to maintain either
light (arousable, able to follow commands) or
deep (unresponsive to stimuli) sedation
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for
the management of pain, agitation, and delirium in adult patients in
the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306.
PMID: 23269131.
6. Evidence Behind PAD 6
AHRQ Safety Program for Mechanically Ventilated Patients
Delirium
Pain, Agitation, and Delirium1
• Delirium is characterized by the acute
onset of cerebral dysfunction with a
change in baseline mental status,
inattention, and either disorganized
thinking or an altered level of
consciousness
• Symptoms commonly associated with
delirium include sleep disturbances and
abnormal psychomotor activity
• Emotional disturbances such as fear,
anxiety, anger, depression, apathy, and
euphoria are also common
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for
the management of pain, agitation, and delirium in adult patients in
the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306.
PMID: 23269131.
7. Evidence Behind PAD 7
AHRQ Safety Program for Mechanically Ventilated Patients
ABCDEF Bundle Checklist2
A – Assess, Prevent, and Manage Pain
B – Both SATs (Spontaneous Awakening Trials) and
SBTs (Spontaneous Breathing Trials)
C – Choice of Sedation
D – Delirium: Assess, Prevent, and Manage
E – Early Mobility and Exercise
F – Family Engagement and Empowerment
2. Balas MC, Devlin JW, Verceles AC, et al. Adapting the ABCDEF bundle to meet the needs
of patients requiring prolonged mechanical ventilation in the long-term acute care hospital
setting: historical perspectives and practical implications. Semin Respir Crit Care Med.
2016 Feb;37(1):119-35. PMID: 26820279.
8. Evidence Behind PAD 8
AHRQ Safety Program for Mechanically Ventilated Patients
ABCDEF Bundle Objectives3-6
• Optimize pain management
• Break the cycle of deep sedation and prolonged mechanical
ventilation
• Reduce the incidence and duration of delirium in the
intensive care unit (ICU) setting
• Improve short- and long-term ICU patient outcomes
• Reduce health care costs
3. Vasilevskis EE, Pandharipande PP, Girard TD, et al. A screening, prevention, and restoration
model for saving the injured brain in intensive care unit survivors. Crit Care Med. 2010 Oct;38(10
Suppl):S683-91. PMID: 21164415.
4. Zaal IJ, Spruyt CF, Peelen LM, et al. Intensive care unit environment may affect the course of
delirium. Intensive Care Med. 2013 Mar;29(3):481-88. PMID: 22804788.
5. Colombo R, Corona A, Praga F, et al. A reorientation strategy for reducing delirium in the critically
ill. Results of an interventional study. Minerva Anestiol. 2012 Sep;78(9):1026-33. PMID: 22772860.
6. ABCDEFs of Prevention and Safety. Nashville, TN: ICU Delirium and Cognitive Impairment Study
Group. 2013. www.icudelirium.org. Accessed Oct 20, 2015.
9. Evidence Behind PAD 9
AHRQ Safety Program for Mechanically Ventilated Patients
ABCDEF Implementation Success: Meta-analysis7
Critical Care
A Systematic Review of Implementation Strategies for Assessment, Prevention, and
Management of ICU Delirium and Their Effect on Clinical Outcomes
Trogrlić et al. 2015
Meta-analysis involved 21 studies, all including
process measures and 9 with clinical outcomes data
7. Trogrlić Z, van der Jagt M, Bakker J, et al. A systematic review of
implementation strategies for assessment, prevention, and management of ICU
delirium and their effect on clinical outcomes. Crit Care. 2015 Apr 9;19(1):157.
PMID: 25888230.
10. Evidence Behind PAD 10
AHRQ Safety Program for Mechanically Ventilated Patients
ABCDEF Implementation Success: Meta-analysis7
• A variety of programs improved process measures
‒ E.g., 92% delirium screening adherence
• Using more than six implementation strategies and
integrating either PAD guidelines or ABCDE bundle
‒ Statistically lower mortality and shorter ICU length of stay
‒ Delirium “incidence” static; delirium duration may be
better metric
• Strategies targeting organizational changes in
addition to provider behavior also associated with
reduced mortality 7. Trogrlić Z, van der Jagt M, Bakker J, et al. A systematic review of
implementation strategies for assessment, prevention, and management of ICU
delirium and their effect on clinical outcomes. Crit Care. 2015 Apr 9;19(1):157.
PMID: 25888230.
11. Evidence Behind PAD 11
AHRQ Safety Program for Mechanically Ventilated Patients
Keystone’s ABCDE Bundle Collaborative Results8
• 51 hospitals in Michigan’s Keystone ICU initiative
• Those implementing combined SATs and delirium
screening were 3.5 times as likely to exercise
ventilated patients
• Incomplete or nonsequential bundle implementation
yielded lower success rates
• Authors concluded that with regard to the ABCDE
bundle, “[T]he whole truly is greater than the sum of
its parts”
8. Miller MA, Govindan S, Watson SR, et al. ABCDE, but in that order?
A cross-sectional survey of Michigan intensive care unit sedation,
delirium, and early mobility practices. Ann Am Thorac Soc. 2015
Jul;12(7):1066-71. PMID: 25970737
12. Evidence Behind PAD 12
AHRQ Safety Program for Mechanically Ventilated Patients
2013 Society of Critical Care Medicine PAD Guidelines1
Critical Care Medicine
Journal of the Society of Critical Care Medicine
Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium
in Adult Patients in the Intensive Care Unit
Barr et al. 2013
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the
management of pain, agitation, and delirium in adult patients in the intensive
care unit. Crit Care Med. 2013 Jan;41(1):263-306. PMID: 23269131.
13. Evidence Behind PAD 13
AHRQ Safety Program for Mechanically Ventilated Patients
1. Establish an overarching and standardized approach
to daily patient management in the intensive care
unit by implementing 2013 PAD Guidelines
2. Assess and treat pain first
3. Avoid benzodiazepines in most patients
4. Either interrupt sedation daily OR target light
sedation
‒ Avoid deep sedation (Richmond Agitation-Sedation Scale
[RASS] score of -4/-5) as it appears harmful; instead,
target awake or alert
2013 Society of Critical Care Medicine PAD Guidelines1
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the
management of pain, agitation, and delirium in adult patients in the intensive
care unit. Crit Care Med. 2013 Jan;41(1):263-306. PMID: 23269131.
14. Evidence Behind PAD 14
AHRQ Safety Program for Mechanically Ventilated Patients
5. Screen for delirium with the Confusion Assessment
Method of the ICU (CAM-ICU) or the Intensive Care
Delirium Screening Checklist (ICDSC)
‒ If delirious, first seek reversible causes and attempt non-
pharmacologic management
6. Use the ABCDEF bundle to improve outcomes for
your patients
2013 Society of Critical Care Medicine PAD Guidelines1
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the
management of pain, agitation, and delirium in adult patients in the intensive
care unit. Crit Care Med. 2013 Jan;41(1):263-306. PMID: 23269131.
15. Evidence Behind PAD 15
AHRQ Safety Program for Mechanically Ventilated Patients
SCCM: PAD Treatment of Delirium Recommendations1
• No published evidence that treatment with
haloperidol reduces the duration of delirium
in adult ICU patients
• Atypical antipsychotics may reduce the
duration of delirium in adult ICU patients
• Rivastigmine NOT recommended to reduce
the duration of delirium in ICU patients
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the
management of pain, agitation, and delirium in adult patients in the intensive
care unit. Crit Care Med. 2013 Jan;41(1):263-306. PMID: 23269131.
16. Evidence Behind PAD 16
AHRQ Safety Program for Mechanically Ventilated Patients
Delirium Screening in the ICU
SCCM’s 2013 PAD clinical practice guidelines
• Recommend these valid and reliable delirium
screening tools
– CAM-ICU
– ICDSC
• Screen moderate- to high-risk patients at least
once per nursing shift
17. Evidence Behind PAD 17
AHRQ Safety Program for Mechanically Ventilated Patients
Don’t Forget About Dr. Dre
Diseases
Sepsis, chronic obstructive
pulmonary disease, congestive
heart failure
Drug Removal
SATs and stopping
benzodiazepines/narcotics
Environment
Immobilization, sleep and
day/night, hearing aids, glasses,
noise
“Monster beats by dre studio” by foeoc kannilc, licensed under CC BY 2.0
18. Evidence Behind PAD 18
AHRQ Safety Program for Mechanically Ventilated Patients
Outcome
Pre-QI
(n=27)
Post-QI
(n=30) P-value
Days with any benzodiazepine use* 150 (50%) 118 (26%) .002
Days alert (RASS -1 to +1) 88 (30%) 311 (67%) <.001
Physical/occupational therapy (PT/OT) in
medical ICU
19 (70%) 28 (93%) .040
Number of PT/OT treatments in ICU 1 (0-3) 7 (3-15) <.001
Days without delirium 61 (21%) 243 (53%) .003
Days of delirium in ICU 107 (36%) 125 (28%)
Days of coma 129 (43%) 86 (19%)
Johns Hopkins Medicine Quality Improvement (QI) Project9
* Benzodiazepine dose (median midazolam mg) from 47 mg down to 15 mg/day
Reduced delirium via fewer benzodiazepines and more mobility
9. Needham DM, Korupolu R, Zanni JM, et al. Early physical medicine and
rehabilitation for patients with acute respiratory failure: a quality improvement
project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. PMID: 20382284.
19. Evidence Behind PAD 19
AHRQ Safety Program for Mechanically Ventilated Patients
Wake Up and Breathe Program Results:
Indiana University10
• N=702 medical ICU/surgical ICU patients
• Implemented paired SATs/SBTs
• Average RASS was one level more arousable
(p<0.0001)
• Prevalence of delirium down 11% (66.7% to 55.3%,
p=0.06)
• Combined prevalence of delirium/coma down by 6%
(p=0.01)
10. Khan BA, Fadel WF, Tricker JL, et al. Effectiveness of implementing a wake up
and breathe program on sedation and delirium in the ICU. Crit Care Med. 2014
Dec;42(12)e791-95. PMID: 25402299.
20. Evidence Behind PAD 20
AHRQ Safety Program for Mechanically Ventilated Patients
1.5-year prospective QI study conducted in 5
ICUs, 1 stepdown unit, and 1 oncology
hematology special care unit within a tertiary
care hospital.
Efficacy and Safety11
Critical Care Medicine
Journal of the Society of Critical Care Medicine
Effectiveness and Safety of the Awakening and Breathing Coordination, Delirium
Monitoring/Management, and Early Exercise/Mobility Bundle
Balas et al. 2014
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening
and breathing coordination, delirium monitoring/management, and early
exercise/mobility bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID: 24394627.
21. Evidence Behind PAD 21
AHRQ Safety Program for Mechanically Ventilated Patients
21
24
19
20
21
22
23
24
25
Ventilator-Free Days
Pre ABDCE Bundle Post ABCDE Bundle
Days
p=0.04
Efficacy and Safety: Ventilator-Free Days11
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening and
breathing coordination, delirium monitoring/management, and early exercise/mobility
bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID: 24394627.
22. Evidence Behind PAD 22
AHRQ Safety Program for Mechanically Ventilated Patients
DELIRIUM RESULTS
62
50
3
48
33
2
0
10
20
30
40
50
60
70
Percent Delirious Percent ICU Days Delirious Days Delirious
Pre ABCDE Bundle Post ABCDE Bundle
p=0.02
p=0.003
Efficacy and Safety: Delirium Results11
Percent
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening and
breathing coordination, delirium monitoring/management, and early exercise/mobility
bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID: 24394627.
23. Evidence Behind PAD 23
AHRQ Safety Program for Mechanically Ventilated Patients
%
48 47
49
66
60
75
0
10
20
30
40
50
60
70
80
Out Of Bed (OOB) ICU OOB Mechanically Ventilated (MV) OOB Non-MV
Pre ABCDE Bundle post ABCDE Bundle
p=0.07
p=0.005
Percent
p=0.005
Efficacy and Safety: Early Mobility Results11
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening and
breathing coordination, delirium monitoring/management, and early exercise/mobility
bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID: 24394627.
24. Evidence Behind PAD 24
AHRQ Safety Program for Mechanically Ventilated Patients
0
2
4
6
8
10
12
14
16
18
20
ICU Total Hospital
Pre ABCDE Bundle Post ABCDE Bundle
16
9
19
11
p=0.04
p=0.07
Percent
28-Day Mortality Results11
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the awakening and
breathing coordination, delirium monitoring/management, and early exercise/mobility
bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID: 24394627.
25. Evidence Behind PAD 25
AHRQ Safety Program for Mechanically Ventilated Patients
Maslow’s Hierarchy of Needs in Critical Care12
Self-Actualization
Incorporating spiritual values into patient care, acceptance of new limitations, reconciliation of new identity
Esteem
Respectful team communication, recognition of dignity/value in each patient, optimizing pre-illness cognition
and physical function through rehabilitation
Love and Belonging
Open visitation of family/friends, family rounds, daily awakening for patient/family interaction, post-ICU
support groups and post-ICU clinics
Safety
Prevention of errors: protocolization/ABCDEs, delirium monitoring and management, hospital-acquired
infections, falls, deep vein thromboses, pressure ulcers, medication errors
Physiological
Support for failing organs (e.g., mechanical ventilation, vasopressors, dialysis), pain and symptom
management, nutrition
12. Jackson JC, Santoro MJ, Ely TM, et al. Improving patient care through the prism of psychology:
application of Maslow's hierarchy to sedation, delirium, and early mobility in the intensive care
unit. J Crit Care. 2014 Jun;29(3):438-44. PMID: 24636724.
26. Evidence Behind PAD 26
AHRQ Safety Program for Mechanically Ventilated Patients
Questions?
27. Evidence Behind PAD 27
AHRQ Safety Program for Mechanically Ventilated Patients
References
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the management
of pain, agitation, and delirium in adult patients in the intensive care unit. Crit
Care Med. 2013 Jan;41(1):263-306. PMID: 23269131.
2. Balas MC, Devlin JW, Verceles AC, et al. Adapting the ABCDEF bundle to meet the
needs of patients requiring prolonged mechanical ventilation in the long-term
acute care hospital setting: historical perspectives and practical implications.
Semin Respir Crit Care Med. 2016 Feb;37(1):119-35. PMID: 26820279.
3. Vasilevskis EE, Pandharipande PP, Girard TD, et al. A screening, prevention, and
restoration model for saving the injured brain in intensive care unit survivors. Crit
Care Med. 2010 Oct;38(10 Suppl):S683-91. PMID: 21164415.
4. Zaal IJ, Spruyt CF, Peelen LM, et al. Intensive care unit environment may affect
the course of delirium. Intensive Care Med. 2013 Mar;29(3):481-88. PMID:
22804788.
28. Evidence Behind PAD 28
AHRQ Safety Program for Mechanically Ventilated Patients
References
5. Colombo R, Corona A, Praga F, et al. A reorientation strategy for reducing
delirium in the critically ill. Results of an interventional study. Minerva Anestiol.
2012 Sep;78(9):1026-33. PMID: 22772860.
6. ABCDEFs of Prevention and Safety. Nashville, TN: ICU Delirium and Cognitive
Impairment Study Group. 2013. www.icudelirium.org. Accessed Oct 20, 2015.
7. Trogrlić Z, van der Jagt M, Bakker J, et al. A systematic review of implementation
strategies for assessment, prevention, and management of ICU delirium and
their effect on clinical outcomes. Crit Care. 2015 Apr 9;19(1):157. PMID:
25888230.
8. Miller MA, Govindan S, Watson SR, et al. ABCDE, but in that order? A cross-
sectional survey of Michigan intensive care unit sedation, delirium, and early
mobility practices. Ann Am Thorac Soc. 2015 Jul;12(7):1066-71. PMID: 25970737.
29. Evidence Behind PAD 29
AHRQ Safety Program for Mechanically Ventilated Patients
References
9. Needham DM, Korupolu R, Zanni JM, et al. Early physical medicine and
rehabilitation for patients with acute respiratory failure: a quality improvement
project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. PMID: 20382284.
10. Khan BA, Fadel WF, Tricker JL, et al. Effectiveness of implementing a wake up and
breathe program on sedation and delirium in the ICU. Crit Care Med. 2014
Dec;42(12)e791-95. PMID: 25402299.
11. Balas MC, Vasilevskis EE, Olsen KM, et al. Effectiveness and safety of the
awakening and breathing coordination, delirium monitoring/management, and
early exercise/mobility bundle. Crit Care Med. 2014 May;42(5):1024-36. PMID:
24394627.
12. Jackson JC, Santoro MJ, Ely TM, et al. Improving patient care through the prism of
psychology: application of Maslow's hierarchy to sedation, delirium, and early
mobility in the intensive care unit. J Crit Care. 2014 Jun;29(3):438-44. PMID:
24636724.