A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals

This study has been completed.

First Received: September 8, 2005 Last Updated: April 24, 2006 History of Changes

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00157287

Purpose

Protocol directed weaning has been shown to reduce the duration of mechanical ventilation for patients admitted to the intensive care unit (ICU) of tertiary centres. However, this benefit has not previously been studied in a community hospital setting. We therefore sought to evaluate the impact of an evidence-based weaning guideline on the outcomes for patients receiving mechanical ventilation in the ICUs of community hospitals in a cluster randomized controlled trial involving 11 community hospitals.

Condition	Intervention	Phase
Respiration, Artificial	Procedure: Evidence based weaning protocol	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

ICU length of stay

Secondary Outcome Measures:

duration of ventilation
length of hospital stay
complications (re-intubation within 48 hours, pneumonia within 48 hours)
ICU mortality
Hospital mortality
ICU readmissions
Qulaity of life

Study Start Date:	June 2003
Estimated Study Completion Date:	July 2005

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients ventilated for more than 24 hours

Exclusion Criteria:

patients less than 16 years of age patients who receive only non-invasive ventilation patients chronically ventilated at time of ICU admission patients who will not be candidates for weaning from ventilation at time of admission If withdrawl of life support is imminent at the point the patient has been ventilated for 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157287

Locations

Canada, Ontario
Joseph Brant Memorial Hospital
Burlington, Ontario, Canada, L7R 4C4
St. Joseph’s Health Care
London, Ontario, Canada, N6A 4V2
North Bay General Hospital
North Bay, Ontario, Canada, P1B 5A4
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Lakeridge Health Corporation (Oshawa)
Oshawa, Ontario, Canada, L1G 2B9
Hotel Dieu of St. Joseph
Windsor, Ontario, Canada, N9A 1E1
Brant Community Health Systems
Brantford, Ontario, Canada, N3R 1G9
William Osler Health Centre (Brampton)
Brampton, Ontario, Canada, N6W 2Z8
St. Joseph’s Health Centre
Toronto, Ontario, Canada, M9R 1B5
Guelph General Hospital
Guelph, Ontario, Canada, N1E 4J4
Stratford General Hospital
Stratford, Ontario, Canada, N5A 2Y6

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:	Ronald J Butler, MD	Lawson Health Research Institute
Principal Investigator:	Claudio Martin, MD	Lawson Health Research Institute
Principal Investigator:	Femida Gwadry-Sridhar, MSc	Lawson Health Research Institute

More Information

No publications provided

Study ID Numbers:	R-01-076, 01-10
Study First Received:	September 8, 2005
Last Updated:	April 24, 2006
ClinicalTrials.gov Identifier:	NCT00157287 History of Changes
Health Authority:	Canada: Health Canada

ClinicalTrials.gov processed this record on May 06, 2009