CDC Prevention Epicenters Wake Up and Breathe Collaborative
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01583413|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 11, 2013
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 or disease||Intervention/treatment||Phase|
|Ventilator-associated Pneumonia||Procedure: Daily SAT & SBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3342 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CDC Prevention Epicenters Wake Up and Breathe Collaborative|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||October 2013|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|