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NCT01583413 · ClinicalTrials.gov registry record · NA
CDC Prevention Epicenters Wake Up and Breathe Collaborative
A NA study, sponsored by Harvard Pilgrim Health Care.
- Completed
- Registry status
- NA
- Development phase
- 3,342
- Enrollment target
NCT01583413: Completed NA study, sponsored by Harvard Pilgrim Health Care.
NCT01583413 is a NA study that has completed, run by Harvard Pilgrim Health Care. The registered enrollment target is 3,342 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01583413, a NA study, has completed, sponsored by Harvard Pilgrim Health Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,342 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 de
Interventions
- PROCEDURE Daily SAT & SBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,342 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT01583413 record still lists
NCT01583413 is an interventional study that assigns participants to a tested intervention. Its 3,342 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (138% higher).
The record links to 0 conditions, and to 1 intervention - of which Daily SAT & SBT is the first listed.
NCT01583413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01583413 about?
NCT01583413 is a clinical study titled "CDC Prevention Epicenters Wake Up and Breathe Collaborative". 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 amo...
What is the current status of trial NCT01583413?
This trial is currently completed. It is a NA study. The enrollment target is 3,342 participants. The study started on 2012-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01583413?
The interventions under investigation include: Daily SAT & SBT (PROCEDURE).
Who is sponsoring clinical trial NCT01583413?
This trial is sponsored by Harvard Pilgrim Health Care, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01583413's enrollment target sits among peer trials
3,342 37th of 2000 higher than 1,964 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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