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CDC Prevention Epicenters Wake Up and Breathe Collaborative
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Purpose
Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation associated with significant morbidity, including prolongation of mechanical ventilation and increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily sedative interruptions and daily spontaneous breathing trials can improve sedative management, decrease ventilator time, improve outcomes for mechanically ventilated patients,and possibly decrease VAP.Combining daily sedative interruption with daily spontaneous breathing trials confers additive improvement in ventilator days, intensive care days, and possibly mortality compared to daily spontaneous breathing trials alone.
The primary aim of this study is to determine the impact of an opt-out protocol for paired daily sedative interruptions and spontaneous breathing trials on VAP rates using a new streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's proposed new surveillance definitions for ventilator-associated events to this quality improvement initiative. The study will be nested within the Epicenters Streamlined versus Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be participating in this intervention arm.
| Condition | Intervention |
|---|---|
| Ventilator-associated Pneumonia | Procedure: Daily SAT & SBT |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CDC Prevention Epicenters Wake Up and Breathe Collaborative |
- Change in VAC rate. [ Time Frame: 12 months ]
A new definition for VAP is the primary focus of this study. This new definition (referred to as "streamlined VAP" or "sVAP") is under consideration by the CDC as a potential replacement for the current NHSN VAP definition and, as such, will be closely evaluated to determine if it can reflect meaningful changes in patient care. Thus, we will assess the change in monthly sVAP rates from study start to study end using an interrupted time series analysis.
Note that CDC released new surveillance definitions for ventilator-associated events in late 2012. Given that CDC definitions are the defacto surveillance standard, we switched the primary study outcome from sVAP to ventilator-associated conditions ("VAC"). All data elements required to assess for VAC were included in this study from the outset hence we did not have to collect any additional historical data in order to apply CDC's VAC definition.
- ICU-specific outcomes [ Time Frame: 12-months ]
- NHSN VAP rate
- Mechanical ventilation days per patient
- Ventilator-free days assessed over 28 days post-intubation
- ICU length of stay per patient
- Average antibiotic days
- Rates of extubation and reintubation within 48 hours
- Hospital-specific outcomes [ Time Frame: 12-months ]
- Hospital length of stay
- Hospital mortality
- Patient-specific outcomes [ Time Frame: 12-months ]
- Mean ventilator days
- Mean ICU days
- Mean hospital days
The above results will also be assessed separately for patients who received opt-out protocol care versus those who did not.
| Enrollment: | 3342 |
| Study Start Date: | May 2012 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Opt Out Protocol |
Procedure: Daily SAT & SBT
Nurse and/or respiratory therapist led daily awakenings from sedation (spontaneous awakening trial, or SAT) and daily performance of a spontaneous breathing trial (SBT) among mechanically ventilated, critically ill patients in participating ICUs.
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- all patients in participating units on mechanical ventilation for at least one calendar day beting treated with continuous sedatives or standing orders for sedatives. Patients receiving mechanical ventilation through either an endotracheal or tracheostomy tube will be eligible.
Exclusion Criteria:
- moribund status or plans for withdrawal of life support
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01583413
| United States, Illinois | |
| Chicago Prevention Epicenter | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| North Shore Medical Center | |
| Salem, Massachusetts, United States | |
| United States, Missouri | |
| Washington University Prevention Epicenter | |
| St. Louis, Missouri, United States | |
| United States, North Carolina | |
| Duke University Prevention Epicenter | |
| Durham, North Carolina, United States | |
| United States, Pennsylvania | |
| University of Pennsylvania Prevention Epicenter | |
| Philadelphia, Pennsylvania, United States | |
| Principal Investigator: | Michael Klompas, MD, MPH | Harvard Pilgrim Health Care |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Klompas MD, MPH, FRCPC, Principal Investigator, Harvard Pilgrim Health Care |
| ClinicalTrials.gov Identifier: | NCT01583413 History of Changes |
| Other Study ID Numbers: |
PH000410A-2 3U54CK000172-01S1 ( U.S. NIH Grant/Contract ) |
| Study First Received: | April 20, 2012 |
| Last Updated: | October 10, 2013 |
Keywords provided by Michael Klompas MD, MPH, FRCPC, Harvard Pilgrim Health Care:
|
Ventilator-associated pneumonia |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Ventilator-Associated Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cross Infection Infection Ventilator-Induced Lung Injury Lung Injury |
ClinicalTrials.gov processed this record on July 21, 2017