1. Evaluation of a
Sedation Vacation
Protocol
Georgianne Summer, BSN, RN
Augusta University
DNP Project Final Defense
2. Introduction
The eradication of healthcare associated infections (HAIs)
is a reimbursement directive set by the US Department of
Health and Human Services (DHHS) and the Centers for
Medicare and Medicaid Services (CMS).
According to the Centers for Disease Control and
Prevention (CDC), hospital-acquired pneumonia (HAP)
accounts for approximately 15% of all HAIs. HAP carries a
crude mortality rate of 30-70% with the predicted
attributable mortality rate of pneumonia between 27-50%.
(Mendel et al., 2011; Tablan et al., 2003)
3. Introduction
Prolonged Length of Stay: According to the CDC, hospital
acquired pneumonia prolongs ICU stay 4-6 days and overall
hospitalization 7-9 days.
Expensive Care: HAP adds $40,000 to the cost of care per
patient
Mechanical ventilation (MV) is estimated to cost as much
as $1,522 per day. In 2003, U.S. hospitals spent 16
billion dollars on PAMV patients. In 2020, the cost will
escalate to $60 billion.
Increased Risk: The National Nosocomial Infection
Surveillance System (NNIS) found that patients receiving
mechanical ventilation had 6-21 times the risk of developing
hospital-associated pneumonia
(Bice et al., 2013; Carson et al., 2006; Zilberg et al., 2008; Zilberg et al., 2012)
4. Introduction
In 2020, an estimated 625,298 patients are projected to require
prolonged acute mechanical ventilation (PAMV), defined as patient
being intubated and using mechanical ventilation ≥ 96 hours.
Due to the significant risk of mechanical ventilation, most of the
research on hospital-associated pneumonia has been focused on
ventilator-associated pneumonia (VAP) for the last 3 decades.
In 2011, the Agency for Healthcare Research and Quality (AHRQ)
developed guidelines to assist in preventing VAP which contains daily
sedation vacation and spontaneous breathing trials.
As healthcare institutions follow the recommended guidelines and
initiate infection prevention and treatment programs, it is essential to
regularly reevaluate their effectiveness.
(Agency for Healthcare Research and Quality, 2011; Tablan et al., 2003)
5. Background
Mechanical ventilation (MV) is a method to assist or replace
spontaneous breathing and indicated when natural ventilation or
respiration is insufficient.
Goals of MV include: maintain gas exchange, reduce myocardial
oxygen consumption, attain lung expansion, and stabilization of
the thoracic wall.
Patient dependency on MV may linger long after the gas
exchange and/or impaired ventilation has resolved.
Comorbidities and severity of underlying disease processes
increases the risk for hospital mortality. This risk increases with
age, hospital acquired infections and multiple organ failure.
(Hamed et al.,2006; Tabers’s Cyclopedic Medical Dictionary, 2013)
6. Background
Patients who survive experience:
prolonged recovery and rehab overcoming hospital acquired
deficits such as decreases in mobility and energy
substantial increase in sleep disorders and social isolation.
Benefits of early weaning from MV include:
Decreased mortality
Improved outcomes
Reduced costs
Decreases in the body’s stress response
Increases in the patient’s comfort level.
(Combes et al., 2003; Hamed et al., 2006)
7. Background
Patients should be assessed daily
To determine if they can tolerate withdrawal of MV and
sustain their own respiratory efforts.
To determine if they can tolerate weaning or
interruption of sedation medication
Critical care specialists remain challenged
To deliver the ideal sedation
Promote relaxation
Decrease unwanted side effects.
(Institute for Clinical Systems Improvement, 2011; Jacobi et al., 2002; Kress et al., 2000;)
8. Background
The Society of Critical Care Medicine (SCCM) guidelines for
ventilator management includes goals to decrease pain, anxiety,
ventilator days, and ICU length of stay.
One guideline of SCCM identifies the desired level of sedation for
mechanical ventilation to be a calm and easily arousable patient.
However, less than 30% of critical care physicians report using
these sedation guidelines or achieving this level of acceptable
sedation.
No matter who institutes the sedation protocol, it remains a nursing
responsibility and their attitudes, judgments and behavior impact
sedation practices.
(Belfort et al., 2009; Guttormson et al., 2010; Lonardo et al., 2014)
9. Problem Statements
While mechanical ventilation is a life-saving intervention, it is
also associated with several potential complications such as
decreased cardiac output, acute lung injury, diaphragmatic
atrophy, oxygen toxicity and barotrauma.
The cost to patients is more than financial, they have referred
to mechanical ventilation as “the most inhumane treatment
ever experienced.”
Although a clinical practice guideline for sedation vacation was
established 11 years ago, it remains a significant practice issue
due to noncompliance by nurses to use this practice guideline.
(Belfort et al., 2009; Chlan et al., 2000; Hamed et al., 2006 Miller et al., 2012; Roberts et al., 2010)
10. Purpose
The purpose of this clinical protocol evaluation
project was to determine if the implementation
of a sedation vacation protocol in a medical
intensive care unit (MICU) reduced the
incidence of pneumonia, duration of intubation
and MICU length of stay for mechanically-
ventilated adult patients.
11. Literature Review
Databases Utilized
CINAHL
PubMed
Ovid MEDLINE
Cochrane Library
Key Search Terms
Intubation
Mechanical
Ventilation
Sedation
Sedation Vacation
Limits
Research in
English language
Research from
2000-2015
Research of
human adult
subjects
Results
190 articles
identified
30 relevant
articles included
Ranked according
to the Stetler
Evidence
Hierarchy System
Picot Question: Does the implementation of a SV protocol in a medical
ICU reduce the incidence of pneumonia, duration of intubation, and ICU
length of stay (LOS) for mechanically-ventilated adult patients?
13. Ventilator Bundle Care
Adherence to bundle care
leads to a significant VAP
reduction
Supported by CDC, AACN,
AHRQ, NIH and IHI.
(Blackwood, 2011; Griffin & Nolan, 2012;IHI, 2012; Lawrence
et al., 2011; Munroe et al., 2014; Stetler et al. 1998)
Literature Review
Ventilator
Bundle
HOB
elevated
Daily SV
Assess
readiness
to wean
Oral care with
chlorhexidine
Peptic ulcer
prophylaxis
DVT
prophylaxis
14. Literature Review
Daily Sedation Vacation
Daily sedation vacations allow for proper assessment of
the patient’s readiness to be extubated.
Evidence indicates that patients who receive daily
interruption of sedation have decreased number of MV
days as well as decreased LOS in the ICU.
Associated with decreased use of sedation and lower
incidence of sedation related side effects.
(American Thoracic Society, 2005; Girard et al., 2008; Jackson et al., 2010; Kress et al., 2000;
Mendez et al., 2013)
15. Literature Review
Spontaneous Breathing Trials
Allows for proper assessment of the patient’s readiness to be
extubated.
Evidence indicates that its use decreases the length of weaning
time, number of MV days, as well as decreased LOS in the ICU.
Used in conjunction with daily sedation vacation.
Recommended American College of Chest Physicians &
American College of Critical Care Medicine.
(AHRQ, 2011; Girard et al., 2008 ;Kahn et al., 2014; MacIntyre, 2001; Marelich, 2000)
16. Literature Review Summary
Introduction of guidelines and protocols, was associated with
improvements in outcomes including ICU and hospital length
of stay, duration of mechanical ventilation, costs, mortality
and reduction of nosocomial infections incidences.
Adherence to IHI recommended bundle led to a significant
reduction of VAP.
Nurse driven protocols were more successful with both
implementation and compliance.
17. Conceptual Framework
Quality and safety are ultimately measured by the degree
to which health care improves significant patient outcomes.
According to the Institute of Medicine quality in health care
is a direct correlation between the level of enhanced health
services and the individual’s and/or population’s anticipated
health outcome.
Donabedian’s Systems model has proven to be an essential
framework for measuring both quality of care and patient
safety in healthcare.
The model has been utilized in quality improvement
research by national and international agencies like WHO,
NIH, AHRQ.
(AHRQ, 2005; AHRQ, 2011)
18. Conceptual Framework
• Application of Donabedian’s Systems Model
Application of Systems Model for process evaluation. Adapted from “Agency for Healthcare Research and Quality U.S. Department of
Health and Human Services. (2007). Closing the quality gap: A critical analysis of quality improvement strategies Volume 7—Care
Coordination Technical Review]”. AHRQ Publication No. 04(07)-0051-7.
Structures
Intensive Care Unit,
patients, physicians,
nurses, respiratory
therapists, policies
and protocols
Processes
Delivery of sedation
vacation guided by
evidence based
protocol
Outcomes
ICU Length of stay,
Incidence of
Pneumonia,
Duration of
mechanical
ventilation
19. Aims
Determine if the utilization of the sedation
vacation protocol in MICU was sustained in
2014
Physicians ordering protocol
Nurses documentation indicated use
Determine if the implementation of the
sedation vacation protocol decreased the
incidence of pneumonia, duration of
intubation, and ICU LOS.
20. Methodology
Design:
Retrospective chart review.
12-month period, January 1, 2014 - December 31, 2014.
Setting:
550 bed Academic Medical Center in Augusta, Georgia
Adult in-patient, 24 bed Medical intensive Care Unit
Sample:
Patients selected by ICD-9 and V codes from the
Enterprise approved EMR data mining tool, I2B2
21. Methodology
Inclusion Criteria Exclusion Criteria
Patients at least 18 years of age
Diagnosis of pneumonia upon
admission to hospital
Patients admitted to the Medical
Intensive Care Unit
Diagnosis of pneumonia upon
admission to Medical Intensive Care
Unit
Patients endotracheally intubated
for ≥ 24 hours
Diagnosis of acute severe laryngeal
edema or any upper airway
obstruction
Patients requiring mechanical
ventilation
Diagnosis of severe acute
respiratory distress syndrome or
status asthmaticus
Patient receiving a continuous
infusion sedative medication
22. Results of Data Mining Search Strategy
348
123
47
33
429
EMRs during 2014 searched using ICD-9 Codes for
Respiratory–related and Mechanical Ventilation diagnoses
81 additional EMRs added with V code for
using a respirator during 2014
# EMRs matched to MICU admissions
# EMRs after excluding no ventilator (7), tracheostomies (7), outside
time frame (22), pre-existing pneumonia (14), DNR/no intubation
order (2), MICU patient in other unit (4), incomplete (7)
Final # EMRs after excluding: no ventilator (1), chronic
ventilator (1), multiple intubations, DNR (2), pre-existing
pneumonia (9)
29. Sample Size
n=33
Frequency Percent p value
Statistical
Significance
Richmond
Agitation
Sedation Scale
Documented
33 100
Spontaneous
Breathing Trial
Documented
23 70 .024
Statistically
Significant
Sedation Titration
Documented
23 70 .024
Statistically
Significant
3 indirect EMR indicators investigated to determine if
the SV protocol was used but not documented.
Results
Cochran’s Q test revealed no statistical significant association was found among
these three SV protocol indicators (p = .92).
30. Results
Indicators of VAP Diagnosis Documentation
Indicators Frequency Percent
Pneumonia Diagnosis documented
Yes 5 15
No 28 85
Total 33 100
Positive Chest X-ray documented
Yes 9 27
No 24 73
Total 33 100
Positive Sputum Culture documented
Yes 12 36
No 21 64
Total 33 100
31. Discussion
Respiratory decompensation accounted for 43% of the
MICU admission diagnoses, many of the patients were
discovered to have positive chest x-rays during the
endotracheal tube verification and therefore VAP could not
be determined.
The duration of ventilation and MICU LOS results are
inconclusive due to the severity of illness within this patient
population, many in this sample were terminally extubated
and therefore have the same number of days for both
endotracheal intubation and MICU length of stay.
32. Discussion
Ventilator Days and MICU LOS in this project were 1.5 and
3 days, respectively, more than that found by Kress et al.
(2000).
Therefore, the 67% compliance shown by the MICU nurses
demonstrated the need for 100% compliance of formal SV
documentation. (If it’s not documented, it’s not done).
Protocol Compliance
Physicians ordering protocol: 100%
Nurses formal documentation of protocol: 67%
Nurses performing SV indicators, but not documenting protocol: 70%
33. Discussion
Survey by Roberts et al. (2010) and other
researchers showed that barriers to protocol
compliance included:
Patient agitation or pain
Nursing acceptance of practice
Fear of patient self-extubation or harm
(Mendez et al., 2013; Miller et al., 2012; Roberts, et al., 2010; Belfort et al., 2009)
35. Implications for Practice:
Educational Opportunities
Critical Care education on sedation with sedation
vacation protocol.
Significance of the sedation weaning and daily
interruption
Importance of documenting rationale for patients
excluded from sedation vacation
Importance of spontaneous breathing trials
Importance of ventilator bundle care
36. Conclusions
While the reviewed evidence supports the use of protocols
for MV and SV with improved outcomes, the findings
suggest that no clear conclusion could be made concerning
the effectiveness of the sedation vacation protocol in this
particular MICU.
Research is needed to accurately determine the efficacy of
the sedation vacation protocol at this facility as well as
compare patient populations based on severity of illness
with other hospital locations across the United States.
37. Plan for dissemination of
Information
Project will be presented to MICU Leadership
Project will be presented AUHealth Evidence Based
Practice/Performance Committee and Education
Committee.
Project will be submitted for publication based on
committee’s recommendation.
Future Conferences TBD
38. Acknowledgements
Committee Chair:
Dr. A. Schumacher, PhD, RN
Committee Member:
Dr. P. Hartley, DNP, RN
Advisors:
William Todd, MSN, RN, FNP-C (DNP site preceptor)
Michelle Sweat, MSN, RN (MICU Nurse Educator)
Joy Hayman (PowerTrials and i2b2 Administrator)
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Editor's Notes
Good Afternoon, I am Georgianne Summer, I am happy to present my DNP project to you today.
The VAP bundle was proposed in 2005 as part of the 100,000 Lives Campaign, an initiative launched by the Institute for Healthcare Improvement.
Ventilator bundle efficacy in one pre and post interventional study decreased VAP from 14.1 cases to 0 in a 12 month period .
Donabedian’s Systems
Structure: Structure refers to the characteristics of the setting in which care takes place. These measures are tangible and easy to assess. Measures used might include: Hospitals, physicians group, clinics, acute care units, personnel, training and policies related to delivery of care. Structure is viewed as not only the approach clinics and hospitals have in organization and operation, but by the policies they have prepared that affect quality of care.
Process: Process evaluates whether a patient received what is considered good quality care. It can refer to anything that is done as part of the interaction between a physician, other health care professional and the patient. This includes providing information and emotional support, as well as cultural competence. It also includes whether a patient’s decisions and preferences are reflected in their care.
Outcomes: Outcomes measure a patient's health condition or change in health condition subsequent to the health care received. They include both intended and unintended outcomes. Recovery, restorative function and survival have been used as indicators of the quality of medical care. For outcomes to be used as quality of care measures, they must reflect, or be responsive to, variations in the care being evaluated.
The design for this project was a retrospective chart review.
The time frame for the project was a 12-month period from January 1, 2014 to December 31, 2014, two years after the implementation of the sedation vacation protocol in January 2012.
All electronic medical records were reviewed of those patients treated in the 24 adult Medical ICU located in the Georgia Regents Medical Center (a 550-bed academic medical center) in Augusta, Georgia during 2014.
The patient population was comprised from the Enterprise approved EMR data mining tool, I2B2.
I started out with 348 charts after searching I2B2 using ICD9 codes
In a separate search there was an additional 81 charts using a v code for respirator. This was done because (difference between V code and ICD 9)
123 matched EMRs were found to be MICU admission from the search of 429
The search was narrowed to 47 after excluding no ventilator (7), tracheostomies(7), outside time frame (22), pre-existing pneumonia (14), DNR/no intubation order (2), MICU patient in other unit (4), incomplete (7)
Finally after getting into the charts a few more patients were excluded due to no ventilator (1), chronic ventilator (1), multiple intubations, DNR (2), pre-existing pneumonia (9) which resulted in a final number of 33 patient charts.
after data was collected descriptive statistics, the nonparametric chi-square test and Cochran’s Q test were performed with a 0.05 level of significance to determine if group differences and association, respectively, was present among the nominal documentation variables for the Sedation Vacation protocol, Spontaneous Breathing Trials, and sedation titration.
Primary (hospital admission) diagnoses grouped by similarity: For example, respiratory decompensation included acute respiratory failure, hypoxia, hypoxemia and dyspnea. Known infectious process included all known patient infections at time of admission such as sepsis, urinary tract infections, empyema, and bacterial endocarditis. The acid-base imbalance diagnosis included acidemia, lactic acidosis, metabolic acidosis and metabolic encephalopathy. All cancer diagnoses were grouped together; the gastrointestinal diagnoses included patients with anemia. Liver failure included liver disease, hepatic encephalopathy, and decompensated cirrhosis. Cardiovascular decompensation included patients experiencing a cardiac arrest, septic shock, and severe hypotension. The miscellaneous category included diagnoses such as kidney injury, generalized edema, and right upper quadrant abdominal pain.
The grouping was the same with MICU admissions
The EMRs of these 33 patients contained documentation establishing that all these intubated patients on mechanical ventilation had physician’s order for the sedation protocol. However, the actual formal documentation of the sedation vacation itself was not as successful. Only 22 EMRs contained documentation that the SV protocol was used, albeit this finding was not statistically significant (p = .056). Clinically though, 2/3 of the nurses did document the use of the protocol. However, this finding does not differentiate between patients who were eligible or not eligible for SV, although a place to EMR exists for documenting the patient’s SV eligibility and the associated reason.
In addition to formally documenting the SV protocol, indirect indicators are used in the EMR to determine if the SV protocol was used but not charted. These indicators include the Richmond Agitation Sedation Scale (RASS), Spontaneous Breathing Trial (SBT), and sedation titration. Statistical analysis showed a significant difference between those charts containing SBT documentation and those that did not (p = .024) as well as with documentation of sedation titration (p =.024). However, no statistical significant association was found among these three SV protocol indicators (p = .92). This shows that many nurses documented in several areas but could not be tracked to charting all by same nurse
Ventilator Associated Pneumonia diagnosis indicators, as seen here, were used in an effort to determine incidences of ventilator associated pneumonia as defined by the CDC as a pneumonia where the patient is on mechanical ventilation for >2 calendar days on the date of diagnosis. The timing of the sputum cultures with intubation was not measured and therefore could not be used in determining VAP.
Gathered in multiple studies by voluntary surveys of nurses. These issues however, are addressed in the GRU sedation protocol with the ability to re-sedate according to RASS, VS and ventilator synchrony.
Several limitations exist for this SV protocol evaluation project. .First, this is a small, single center study conducted at an academic medical center that serves a large indigent population. This study cannot automatically be universally applied to other institutions, a larger sample size, covering a broader time period, may provide more statistically significant results. Secondly, the enterprise-approved database contained no criteria or variables for searching by location with the I2B2 data mining tool, which prevented isolating only the MICU patient population. Finally, qualified EMRs were found using ICD-9 codes, but inconsistent medical coding caused inaccurate capture of some patient records while possibly not capturing others who should have been included in this SV protocol evaluation. The variations in physician charting led to patients being added to the study who were later discovered not to meet the inclusion and exclusion criteria. A more accurate systematic method is needed of capturing EMRs based on patient location, procedures, and medical or nursing diagnoses.
Education with all critical care nurses is needed to discuss the sedation and sedation vacation protocols. Display studies that support the practice and the importance of the sedation weaning and daily interruption and their positive outcomes on mechanically ventilated patients. Demonstrate who meets the criteria and those who should be excluded form sedation vacation and Explain rationale for patients i.e. how they met the exclusion criteria. Training with nurses and respiratory staff on the significance of working as a team to complete the spontaneous breathing trials and ventilator bundle care.