CDC Prevention Epicenters Wake Up and Breathe Collaborative

Ventilator-associated Pneumonia Clinical Trial

Official title:

CDC Prevention Epicenters Wake Up and Breathe Collaborative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583413
• Other study ID #: PH000410A-2
• Secondary ID: 3U54CK000172-01S
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: October 10, 2013
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3342
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

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.

Locations

Country	Name	City	State
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	North Shore Medical Center	Salem	Massachusetts
United States	Washington University Prevention Epicenter	St. Louis	Missouri

Sponsors (7)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Centers for Disease Control and Prevention, Duke University, North Shore Medical Center, Rush University Medical Center, University of Pennsylvania, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAC rate.	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.	12 months	No
Secondary	ICU-specific outcomes	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	12-months	No
Secondary	Hospital-specific outcomes	Hospital length of stay; Hospital mortality	12-months	No
Secondary	Patient-specific outcomes	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.	12-months	No