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CDC Prevention Epicenters Wake Up and Breathe Collaborative

CDC Prevention Epicenters Wake Up and Breathe Collaborative

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01583413
Enrollment
3342
Registered
2012-04-24
Start date
2012-05-31
Completion date
2013-10-31
Last updated
2013-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-associated Pneumonia

Keywords

Ventilator-associated pneumonia

Brief 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.

Interventions

PROCEDUREDaily 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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Washington University School of Medicine
CollaboratorOTHER
Rush University Medical Center
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Duke University
CollaboratorOTHER
North Shore Medical Center
CollaboratorOTHER
Harvard Pilgrim Health Care
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Change in VAC rate.12 monthsA 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.

Secondary

MeasureTime frameDescription
ICU-specific outcomes12-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 outcomes12-months* Hospital length of stay * Hospital mortality
Patient-specific outcomes12-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026