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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157287
First Posted: September 12, 2005
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals

Resource links provided by NLM:


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
Study Completion Date: April 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157287


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

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00157287     History of Changes
Other Study ID Numbers: R-01-076
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No