Mechanical Ventilation Discontinuation Practices

NCT ID: NCT03955874

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1868 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-04
• Study Completion Date: 2016-12-17

Brief Summary

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

Detailed Description

Background: The requirement for mechanical ventilation 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 mechanical ventilation is dedicated to weaning. The extent and predictors of practice variation in how this complicated and expensive technology is discontinued from critically ill patients remains unknown. Meanwhile, practice pattern variability has been shown to adversely impact upon patient safety and important clinical outcomes.

Primary Objectives:

1. To describe weaning practice variation with regard to the (i) use of daily screening, (ii) preferred methods of support used before initial discontinuation attempts, (iii) use of written weaning and spontaneous breathing trial (SBT) protocols, (iv) preferred methods used to conduct SBTs and (v) sedation and mobilization practices among geographic regions.

2. To describe the association between variation in weaning practices (direct extubation, tracheostomy, SBT conduct) and important clinical outcomes.

Secondary Objectives:

3. To identify baseline and time-dependent factors associated with use of selected strategies.

4. Among critically ill adults who undergo an initial SBT, the investigators will: a) investigate associations between SBT outcome (success/failure) and clinical outcomes, b) explore differences between critically ill patients who undergo an SBT early versus later in their intensive care unit (ICU) stay, and c) investigate the impact of different SBT techniques and humidification strategies on outcomes.

5. To identify important predictors (patient, clinician, SBT, institutional and regional) of SBT outcome.

Study Design and Population: The investigators propose to conduct an international prospective observational study of mechanical ventilation discontinuation practices in 150 ICUs involving all newly admitted critically ill adults requiring invasive ventilation for at least 24 hours.

Study Centres: Interested centres have been identified through completion of an information card enclosed in a previously administered International Weaning Survey. The investigators will use a multimodal approach to identify participating centers in each of the 6 geographic regions (Canada, the United States, the United Kingdom, Europe, India and Australia/New Zealand).

Study Outcomes: The investigators will classify each new admission over the study week according to the initial strategy that precipitated or facilitated mechanical ventilation discontinuation into one of five categories: direct extubation, tracheostomy, SBT success, SBT failure or death. The investigator will describe the association between the use of alternative discontinuation strategies and important clinical outcomes (e.g., mortality, ICU and hospital stay, ICU readmission and reintubation rates).

Relevance: Through collaborations with industry partners and international colleagues we will implement this large scale observational study to quantify the existence and extent of practice variation in weaning. Information obtained from this study will inform the design of future studies aimed at reducing weaning practice variation and improving outcomes in critically ill patients receiving invasive mechanical ventilation

Conditions

Invasive Mechanical Ventilation; Critical Illness; Spontaneous Breathing Trial; Weaning Invasive Mechanical Ventilation; Tracheostomy; Direct Extubation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

INITIAL SBT

Patients who underwent an Spontaneous Breathing Trial prior to extubation. This cohort will be further subdivided into initial patients who initially pass an SBT successes and those who initially fail an SBT.

No interventions assigned to this group

DIRECT EXTUBATION

Patients that were directly extubated without conduct of a prior SBT or tracheostomy

No interventions assigned to this group

DIRECT TRACHEOSTOMY

Patients who underwent a direct tracheostomy without conduct of a prior SBT or extubation

No interventions assigned to this group

No attempt at mechanical ventilation discontinuation

Patients who died without conduct of a prior SBT, extubation or tracheostomy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen E.A. Burns, MD, FRCPC, MSc

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto

Locations

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

Countries

United States; Canada

References

Burns KEA, Rizvi L, Cook DJ, Lebovic G, Dodek P, Villar J, Slutsky AS, Jones A, Kapadia FN, Gattas DJ, Epstein SK, Pelosi P, Kefala K, Meade MO; Canadian Critical Care Trials Group. Ventilator Weaning and Discontinuation Practices for Critically Ill Patients. JAMA. 2021 Mar 23;325(12):1173-1184. doi: 10.1001/jama.2021.2384.

Reference Type: BACKGROUND

PMID: 33755077 (View on PubMed)

Burns KEA, Rizvi L, Cook DJ, Dodek P, Slutsky AS, Jones A, Villar J, Kapadia FN, Gattas DJ, Epstein SK, Meade MO; Canadian Critical Care Trials Group. Variation in the practice of discontinuing mechanical ventilation in critically ill adults: study protocol for an international prospective observational study. BMJ Open. 2019 Sep 8;9(9):e031775. doi: 10.1136/bmjopen-2019-031775.

Reference Type: DERIVED

PMID: 31501132 (View on PubMed)

Other Identifiers

11-024

Identifier Type: -

Identifier Source: org_study_id