Invasive Mechanical VentilationIOSNCT03955874

Mechanical Ventilation Discontinuation Practices

An observational study of Invasive Mechanical Ventilation and Critical Illness, run by Unity Health Toronto at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Invasive Mechanical Ventilation, Critical Illness, Spontaneous Breathing Trial
How many people: 1,868 participants
Where: 14 sitesin 2 countries
Study dates: 4 Nov 2013to 17 Dec 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

Canada12 sites

Hamilton Health Sciences Hamilton General Hospital
Hamilton, Ontario, L8L2X2
Juravinski Hospital Cancer Centre
Hamilton, Ontario
St. Joseph's Hospital
Hamilton, Ontario
London Health Sciences Centre - University Hospital Campus
London, Ontario, N6A 5A5
Hôpital Saint-Luc
Montreal, Quebec, H2X 3J4
Ottawa Civic Hospital
Ottawa, Ontario
Ottawa General Hospital
Ottawa, Ontario
Universite de Sherbrooke
Sherbrooke, Quebec
Universite Hopitalier de Sherbrooke
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario
Ciusss McQ
Trois-Rivières, Quebec, G9A5C5

Other trials in Canada

United States2 sites

University of Michigan Health System
Ann Arbor, Michigan, 48109
Tufts Medical Center
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: Practice Pattern Variation in Discontinuing Mechanical Ventilation in Critically Ill Adults: An International Prospective Observational Study

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

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).
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

Read the 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:

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.
To describe the association between variation in weaning practices (direct extubation, tracheostomy, SBT conduct) and important clinical outcomes. Secondary Objectives:
To identify baseline and time-dependent factors associated with use of selected strategies.
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.
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
Medical subject headings: Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03955874
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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.)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
We will use cox proportion hazards modelling to identify baseline characteristics and time-dependent factors (development of adult respiratory distress syndrome, heart failure, acute kidney injury requiring dialysis) associated with the use of selected discontinuation strategies (direct extubation, direct tracheostomy, Initial SBT)
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and total duration of ventilation.
Describe the associations between SBT outcome (success/failure) and the total duration of ventilation.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU mortality.
Describe the associations between SBT outcome (success/failure) and ICU mortality.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and hospital mortality.
Describe the associations between SBT outcome (success/failure) and hospital mortality.
Measured: 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
Describe the associations between SBT outcome (success/failure) and the proportion of patients off the ventilator at day 28.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and the proportion of patients out of the ICU at day 28.
Describe the associations between SBT outcome (success/failure) and the proportion of patients out of the ICU at day 28.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU LOS.
Describe the associations between SBT outcome (success/failure) and ICU LOS (total and among survivors and non survivors.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and hospital LOS.
Describe the associations between SBT outcome (success/failure) and hospital LOS (total and among survivors and non survivors.
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU readmission.
Association between initial SBT outcome (success/failure) and ICU readmission (during the current hospitalization).
Measured: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and reintubation.
Describe the associations between SBT outcome (success/failure) and reintubation (or repeat ventilation following disconnection in tracheostomized patients) within 48 hours of extubation
1. Describe the association between different SBT techniques on clinical outcomes and d) Describe the association between use of selected humidification strategies and clinical outcomes.
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on the total duration of ventilation.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the total duration of ventilation.
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU mortality.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU mortality.
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital mortality.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital mortality.
Measured: Through study completion (approximately 4 years)
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.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the proportion of patients off the ventilator at day 28.
Measured: Through study completion (approximately 4 years)
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.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the proportion of patients out of the ICU at day 28.
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU LOS.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital LOS.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU readmission.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU readmission (during the current hospitalization).
Measured: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on reintubation.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on reintubation (or repeat ventilation following disconnection in tracheostomized patients) within 48 hours of extubation.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and total duration of ventilation.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the total duration of ventilation.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU mortality.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU mortality.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and hospital mortality.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital mortality.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and the proportion of patients off the ventilator at day 28.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the proportion of patients off the ventilator at day 28.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and the proportion of patients out of the ICU at day 28.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the proportion of patients out of the ICU at day 28.
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU LOS.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and hospital LOS.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU readmission.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU readmission (during the current hospitalization).
Measured: Through study completion (approximately 4 years)
Association between different SBT techniques and reintubation.
Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on reintubation (or repeat ventilation following disconnection in tracheostomized patients) within 48 hours of extubation
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the total duration of ventilation.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on the total duration of ventilation.
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU mortality.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on ICU mortality.
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and hospital mortality.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on hospital mortality.
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the proportion of patients off the ventilator at day 28.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on the proportion of patients off the ventilator at day 28.
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the proportion of patients out of the ICU at day 28.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on the proportion of patients out of the ICU at day 28.
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU LOS.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on ICU LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and hospital LOS.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on hospital LOS (total and among survivors and non survivors).
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU readmission.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on ICU readmission (during the current hospitalization).
Measured: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and reintubation.
Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on reintubation (or repeat ventilation following disconnection in tracheostomized patients) within 48 hours of extubation.
Measured: Through study completion (approximately 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 201317 Dec 2016

First posted20 May 2019
Study start4 Nov 2013
Primary completion17 Dec 2016
Study completion17 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,868 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03955874
Sponsor's protocol ID: 11-024
Acronym: IOS
Status last verified: Mar 2021
First submitted: 3 May 2019
Last updated: 2 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 33755077
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.
PubMed 31501132

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Physiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation
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All Invasive Mechanical Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Practice Pattern Variation in Discontinuing Mechanical Ventilation in Critically Ill Adults: An International Prospective Observational Study
ClinicalTrials.gov ID: NCT03955874
Acronym / sponsor ID: IOS / 11-024
Conditions: Invasive Mechanical Ventilation, Critical Illness, Spontaneous Breathing Trial, Weaning Invasive Mechanical Ventilation, Tracheostomy, Direct Extubation
Study type: Observational
Recruitment status: Completed
Enrolment: 1,868 participants (actual)
Lead sponsor: Unity Health TorontoUniversity, hospital or other
Study start: 4 Nov 2013 (actual)
Primary completion: 17 Dec 2016 (actual)
Study completion: 17 Dec 2016 (actual)
First posted: 20 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objectives: To describe

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

Relevance: This novel study will build collaborations with critical care investigators from around the world and industry

Detailed description

Primary Objectives:

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.
To describe the association between variation in weaning practices (direct extubation, tracheostomy, SBT conduct) and important clinical outcomes. Secondary Objectives:
To identify baseline and time-dependent factors associated with use of selected strategies.
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.
To identify important predictors (patient, clinician, SBT, institutional and regional) of SBT outcome.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Practice variation among geographic regions in the use of daily screening to identify candidates to undergo an SBT
Time frame: Through study completion (approximately 4 years)
Use of once daily screening in clinical practice
Practice variation among geographic regions in the preferred methods of ventilator support used before initial discontinuation attempts
Time frame: Through study completion (approximately 4 years)
Differences in ventilator modes (Pressure Support, Assist Control, other) prior to discontinuation attempts
Practice variation among geographic regions in the use of written weaning and SBT protocols
Time frame: Through study completion (approximately 4 years)
Use of written protocols to liberate patients from ventilators
Practice variation among geographic regions in the methods used to conduct SBTs (and humidify oxygen)
Time frame: Through study completion (approximately 4 years)
Use of different techniques to conduct SBTs (Pressure Support, T-piece, etc.)
Practice variation among geographic regions in the sedation and mobilization practices during weaning
Time frame: Through study completion (approximately 4 years)
Use of different levels of sedation (Sedation Agitation Scale) and levels of mobilization (active, passive, none)
Association between variation in the weaning practices and total duration of ventilation.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and the total duration of ventilation.
Association between variation in the weaning practices and ICU mortality
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and ICU mortality.
Association between variation in the weaning practices and hospital mortality.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and hospital mortality.
Association between variation in the weaning practices and the proportion of patients off the ventilator at day 28.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and the proportion of patients off the ventilator at day 28.
Association between variation in the weaning practices and the proportion of patients out of the ICU at day 28.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and the proportion of patients out of the ICU at day 28.
Association between variation in the weaning practices and ICU LOS.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and ICU LOS (total and among survivors and non survivors).
Association between variation in the weaning practices and hospital LOS.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and hospital LOS (total and among survivors and non survivors).
Association between variation in the weaning practices and ICU readmission.
Time frame: Through study completion (approximately 4 years)
We will describe the association between variation in the weaning practices and ICU readmission (during the current hospitalization).
Association between variation in the weaning practices and reintubation.
Time frame: Through study completion (approximately 4 years)
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.

37 secondary outcomes

Identify baseline characteristics and time-dependent factors associated with use of selected strategy (direct extubation, direct tracheostomy, Initial SBT) to discontinue mechanical ventilation
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and total duration of ventilation.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU mortality.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and hospital mortality.
Time frame: 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
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and the proportion of patients out of the ICU at day 28.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU LOS.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and hospital LOS.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and ICU readmission.
Time frame: Through study completion (approximately 4 years)
Association between initial SBT outcome (success/failure) and reintubation.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on the total duration of ventilation.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU mortality.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital mortality.
Time frame: Through study completion (approximately 4 years)
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.
Time frame: Through study completion (approximately 4 years)
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.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU LOS.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on hospital LOS.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on ICU readmission.
Time frame: Through study completion (approximately 4 years)
Differences in clinical outcomes between patients who undergo an SBT early versus later in their ICU stay on reintubation.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and total duration of ventilation.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU mortality.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and hospital mortality.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and the proportion of patients off the ventilator at day 28.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and the proportion of patients out of the ICU at day 28.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU LOS.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and hospital LOS.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and ICU readmission.
Time frame: Through study completion (approximately 4 years)
Association between different SBT techniques and reintubation.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the total duration of ventilation.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU mortality.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and hospital mortality.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the proportion of patients off the ventilator at day 28.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and the proportion of patients out of the ICU at day 28.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU LOS.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and hospital LOS.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and ICU readmission.
Time frame: Through study completion (approximately 4 years)
Association between use of selected humidification strategies and reintubation.
Time frame: Through study completion (approximately 4 years)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Background: PubMed 33755077Burns 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.
Derived from this study: PubMed 31501132Burns 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

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

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Invasive Mechanical Ventilation and Critical Illness, run by Unity Health Toronto at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Practice variation among geographic regions in the use of daily screening to identify candidates to undergo an SBT (time frame: Through study completion (approximately 4 years)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.