Mechanical Ventilation Discontinuation Practices

Completed

Conditions studied: Invasive Mechanical Ventilation, Critical Illness, Spontaneous Breathing Trial, Weaning Invasive Mechanical Ventilation, Tracheostomy, Direct Extubation

In brief

Background: The requirement for ventilator support is a defining feature of critical illness. Weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the total time spent on ventilators is dedicated to weaning. The extent of practice variation in how this complex and expensive technology is discontinued from critically ill patients is unknown. Meanwhile, practice variation has been shown to adversely impact upon patient safety and clinical outcomes. Purpose: To characterize practice pattern variation in weaning and the consequences of weaning variation by implementing an international, prospective observational study in Canada, the United States, the United Kingdom, Europe, India and Australia/New Zealand. Primary Objectives: To describe 1. weaning practice variation among regions in 5 domains (the use of daily screening, preferred methods of support used before initial discontinuation attempts, use of written protocols, preferred methods of evaluating spontaneous breathing, and sedation and mobilization practices). 2. the assocation between selected discontinuation strategies and important clinical outcomes (length of stay, mortality, duration of ventilation). Methods: The investigators propose to conduct a large scale, observational study involving critically ill adults requiring ventilator support for at least 24 hours to evaluate practices in discontinuing ventilators in 150 centres. The investigators will classify each new admission over the observation period according to the initial strategy that precipitated or facilitated ventilator discontinuation. Relevance: This novel study will build collaborations with critical care investigators from around the world and industry

Key facts

Study ID

NCT03955874

Run by

Unity Health Toronto

People needed

1868

Starts

2013-11-04

Expected to finish

2016-12-17

Last updated by the study team

2021-04-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All newly admitted critically ill adults after study initiation at participating ICUs.
• Requiring invasive mechanical ventilation for at least 24 (i.e. > or equal to 24) hours

You may not qualify if…

• Transferred to a participating ICU without a clear time of intubation
• Tracheotomy/tracheostomy present at the time of ICU admission
• Already on ventilator settings compatible with a SBT [e.g., T-piece or Continuous Positive Airway Pressure < or =5 cm H2O (water) or Pressure Support < or = 8 cm H2O (with or without PEEP) or Automatic Tube Compensation (ATC) or equivalent] at the time of ICU admission
• Patient residing in ICU for > or = 24 hours at the time of the study activation (i.e., not a new admission from the time of study activation).
• Patient readmitted to this ICU during the study period (i.e., would constitute a second inclusion) unless they were ineligible during their first admission
• Patients participating in studies (e.g., randomized controlled trials) with explicit weaning protocols incorporated into the study design

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Hamilton Health Sciences Hamilton General Hospital — Hamilton, Ontario, Canada
• Juravinski Hospital Cancer Centre — Hamilton, Ontario, Canada
• St. Joseph's Hospital — Hamilton, Ontario, Canada
• London Health Sciences Centre - University Hospital Campus — London, Ontario, Canada
• Ottawa Civic Hospital — Ottawa, Ontario, Canada
• Ottawa General Hospital — Ottawa, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Hôpital Saint-Luc — Montreal, Quebec, Canada
• Universite de Sherbrooke — Sherbrooke, Quebec, Canada
• Universite Hopitalier de Sherbrooke — Sherbrooke, Quebec, Canada
• Ciusss McQ — Trois-Rivières, Quebec, Canada

Full record on ClinicalTrials.gov

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