Clinical trial NCT03955874: Mechanical Ventilation Discontinuation Practices
Official title: Practice Pattern Variation in Discontinuing Mechanical Ventilation in Critically Ill Adults: An International Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Mechanical Ventilation
Critical Illness
Spontaneous Breathing Trial
Weaning Invasive Mechanical Ventilation
Tracheostomy
Direct Extubation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 1868
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Primary outcomes:
measure: Practice variation among geographic regions in the use of daily screening to identify candidates to undergo an SBT
timeFrame: Through study completion (approximately 4 years)
measure: Practice variation among geographic regions in the preferred methods of ventilator support used before initial discontinuation attempts
timeFrame: Through study completion (approximately 4 years)
measure: Practice variation among geographic regions in the use of written weaning and SBT protocols
timeFrame: Through study completion (approximately 4 years)
measure: Practice variation among geographic regions in the methods used to conduct SBTs (and humidify oxygen)
timeFrame: Through study completion (approximately 4 years)
measure: Practice variation among geographic regions in the sedation and mobilization practices during weaning
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and total duration of ventilation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and ICU mortality
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and hospital mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and the proportion of patients off the ventilator at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and the proportion of patients out of the ICU at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and ICU LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and hospital LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and ICU readmission.
timeFrame: Through study completion (approximately 4 years)
measure: Association between variation in the weaning practices and reintubation.
timeFrame: Through study completion (approximately 4 years)
Secondary outcomes:
measure: Identify baseline characteristics and time-dependent factors associated with use of selected strategy (direct extubation, direct tracheostomy, Initial SBT) to discontinue mechanical ventilation
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and total duration of ventilation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and ICU mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and hospital mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and the proportion of patients off of the ventilator at day 28
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and the proportion of patients out of the ICU at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and ICU LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and hospital LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and ICU readmission.
timeFrame: Through study completion (approximately 4 years)
measure: Association between initial SBT outcome (success/failure) and reintubation.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on the total duration of ventilation.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on the proportion of patients off the ventilator at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on the proportion of patients out of the ICU at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU readmission.
timeFrame: Through study completion (approximately 4 years)
measure: Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on reintubation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and total duration of ventilation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and ICU mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and hospital mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and the proportion of patients off the ventilator at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and the proportion of patients out of the ICU at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and ICU LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and hospital LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and ICU readmission.
timeFrame: Through study completion (approximately 4 years)
measure: Association between different SBT techniques and reintubation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and the total duration of ventilation.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and ICU mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and hospital mortality.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and the proportion of patients off the ventilator at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and the proportion of patients out of the ICU at day 28.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and ICU LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and hospital LOS.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and ICU readmission.
timeFrame: Through study completion (approximately 4 years)
measure: Association between use of selected humidification strategies and reintubation.
timeFrame: Through study completion (approximately 4 years)
Other outcomes:
measure: Predictors of initial SBT outcome.
timeFrame: Through study completion (approximately 4 years)
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital Cancer Centre
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital Campus
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Civic Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Saint-Luc
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite de Sherbrooke
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite Hopitalier de Sherbrooke
state: Quebec
city: Trois-Rivières
country: Canada
facility: Ciusss McQ
state: Quebec
Study officials:
affiliation: St. Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto
name: Karen E.A. Burns, MD, FRCPC, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.