CDC Prevention Epicenters Wake Up and Breathe Collaborative

Not Applicable

Completed

• Conditions: Ventilator-associated Pneumonia
• Interventions: Procedure: Daily SAT & SBT

• Registration Number: NCT01583413
• Lead Sponsor: Harvard Pilgrim Health Care

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-24
• Study Start: 2012-05
• Primary Completion: 2013-06
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Opt Out Protocol	Daily SAT & SBT	-

Primary Outcome Measures

Name	Time	Method
Change in VAC rate.	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.

Secondary Outcome Measures

Name	Time	Method
Hospital-specific outcomes	12-months	* Hospital length of stay; * Hospital mortality
Patient-specific outcomes	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.
ICU-specific outcomes	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

Trial Locations

Locations (5)

North Shore Medical Center; 🇺🇸 Salem, Massachusetts, United States

Washington University Prevention Epicenter; 🇺🇸 St. Louis, Missouri, United States

Chicago Prevention Epicenter; 🇺🇸 Chicago, Illinois, United States

Duke University Prevention Epicenter; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania Prevention Epicenter; 🇺🇸 Philadelphia, Pennsylvania, United States