NCT03955874: IOS

Mechanical Ventilation Discontinuation Practices

Completed Last updated 2 April 2021

What this trial tests

trial in Invasive Mechanical Ventilation in 1,868 participants. Completed in 17 December 2016.

Timeline

4 November 2013

Primary endpoint
17 December 2016

17 December 2016

Quick facts

Lead sponsor	Unity Health Toronto
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,868
Start date	4 November 2013
Primary completion	17 December 2016
Estimated completion	17 December 2016
Sites	14 locations across Canada, United States

Conditions studied

• Invasive Mechanical Ventilation — all drugs for Invasive Mechanical Ventilation →
• Critical Illness — all drugs for Critical Illness →
• Spontaneous Breathing Trial — all drugs for Spontaneous Breathing Trial →
• Weaning Invasive Mechanical Ventilation — all drugs for Weaning Invasive Mechanical Ventilation →

Sponsor

Unity Health Toronto — full company profile →

Who can join

16 and older, any sex, with Invasive Mechanical Ventilation or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ventilator Weaning and Discontinuation Practices for Critically Ill Patients.
   Burns KEA, Rizvi L, Cook DJ, Lebovic G, et al · · 2021 · cited 95× · PMID 33755077 · DOI 10.1001/jama.2021.2384
2. Variation in the practice of discontinuing mechanical ventilation in critically ill adults: study protocol for an international prospective observational study.
   Burns KEA, Rizvi L, Cook DJ, Dodek P, et al · · 2019 · cited 4× · PMID 31501132 · DOI 10.1136/bmjopen-2019-031775