Mechanical Ventilation Discontinuation Practices

NCT03955874 | Completed

• 1 other identifier: 11-024
• Study Type: observational
• Target: 1,868
• Locations: 2 countries
• Sites: 14

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. 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. 2.the assocation between selected discontinuation strategies and important clinical outcomes (length of stay, mortality, duration of ventilation).

Conditions

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

Outcome Measures

Primary Outcomes (14)

• Practice variation among geographic regions in the use of daily screening to identify candidates to undergo an SBT

  Use of once daily screening in clinical practice

  Through study completion (approximately 4 years)

• Practice variation among geographic regions in the preferred methods of ventilator support used before initial discontinuation attempts

  Differences in ventilator modes (Pressure Support, Assist Control, other) prior to discontinuation attempts

  Through study completion (approximately 4 years)

• Practice variation among geographic regions in the use of written weaning and SBT protocols

  Use of written protocols to liberate patients from ventilators

  Through study completion (approximately 4 years)

• Practice variation among geographic regions in the methods used to conduct SBTs (and humidify oxygen)

  Use of different techniques to conduct SBTs (Pressure Support, T-piece, etc.)

  Through study completion (approximately 4 years)

• Practice variation among geographic regions in the sedation and mobilization practices during weaning

  Use of different levels of sedation (Sedation Agitation Scale) and levels of mobilization (active, passive, none)

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and total duration of ventilation.

  We will describe the association between variation in the weaning practices and the total duration of ventilation.

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and ICU mortality

  We will describe the association between variation in the weaning practices and ICU mortality.

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and hospital mortality.

  We will describe the association between variation in the weaning practices and hospital mortality.

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and the proportion of patients off the ventilator at day 28.

  We will describe the association between variation in the weaning practices and the proportion of patients off the ventilator at day 28.

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and the proportion of patients out of the ICU at day 28.

  We will describe the association between variation in the weaning practices and the proportion of patients out of the ICU at day 28.

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and ICU LOS.

  We will describe the association between variation in the weaning practices and ICU LOS (total and among survivors and non survivors).

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and hospital LOS.

  We will describe the association between variation in the weaning practices and hospital LOS (total and among survivors and non survivors).

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and ICU readmission.

  We will describe the association between variation in the weaning practices and ICU readmission (during the current hospitalization).

  Through study completion (approximately 4 years)

• Association between variation in the weaning practices and reintubation.

  We will describe the association between variation in the weaning practices and reintubation (or repeat ventilation following disconnection in tracheostomized patients) within 48 hours of extubation.

  Through study completion (approximately 4 years)

Secondary Outcomes (37)

• Identify baseline characteristics and time-dependent factors associated with use of selected strategy (direct extubation, direct tracheostomy, Initial SBT) to discontinue mechanical ventilation

  Through study completion (approximately 4 years)

• Association between initial SBT outcome (success/failure) and total duration of ventilation.

  Through study completion (approximately 4 years)

• Association between initial SBT outcome (success/failure) and ICU mortality.

  Through study completion (approximately 4 years)

• Association between initial SBT outcome (success/failure) and hospital mortality.

  Through study completion (approximately 4 years)

• Association between initial SBT outcome (success/failure) and the proportion of patients off of the ventilator at day 28

  Through study completion (approximately 4 years)

Other Outcomes (1)

• Predictors of initial SBT outcome.

  Through study completion (approximately 4 years)

Study Arms (4)

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.

DIRECT EXTUBATION

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

DIRECT TRACHEOSTOMY

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

No attempt at mechanical ventilation discontinuation

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We propose to conduct an International, Prospective Observational Study of Mechanical Ventilation Discontinuation Practices among critically ill adults who receive invasive mechanical ventilation for at least 24 (i.e., \> or equal to 24) hours in approximately 150 international ICUs

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).
• Patients participating in studies (e.g., randomized controlled trials) with explicit weaning protocols incorporated into the study design

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (14)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Hamilton Health Sciences Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

Juravinski Hospital Cancer Centre

Hamilton, Ontario, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre - University Hospital Campus

London, Ontario, N6A 5A5, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Hôpital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

Universite de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Universite Hopitalier de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Ciusss McQ

Trois-Rivières, Quebec, G9A5C5, Canada

Location

Related Publications (2)

• 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.

  PMID: 33755077 BACKGROUND

• 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.

  PMID: 31501132 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen E.A. Burns, MD, FRCPC, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 20, 2019
• Study Start: November 4, 2013
• Primary Completion: December 17, 2016
• Study Completion: December 17, 2016
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

US (2); CA (12)