Mechanical Ventilation Discontinuation Practices

Critical Illness Clinical Trial

— IOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955874
• Other study ID #: 11-024
• Status: Completed
• Start date: November 4, 2013
• Est. completion date: December 17, 2016

Study information

• Verified date: March 2021
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1868
• Est. completion date: December 17, 2016
• Est. primary completion date: December 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	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	Hôpital Saint-Luc	Montréal	Quebec
Canada	Ottawa Civic Hospital	Ottawa	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Universite de Sherbrooke	Sherbrooke	Quebec
Canada	Universite Hopitalier de Sherbrooke	Sherbrooke	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Ciusss McQ	Trois-Rivières	Quebec
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictors of initial SBT outcome.	Describe important predictors (patient, clinician, SBT, institutional and regional-related) of initial SBT outcome (SBT success and failure) using a single regression analysis. One analysis will be conducted to describe significant predictors.	Through study completion (approximately 4 years)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	Association between initial SBT outcome (success/failure) and ICU mortality.	Describe the associations between SBT outcome (success/failure) and ICU mortality.	Through study completion (approximately 4 years)
Secondary	Association between initial SBT outcome (success/failure) and hospital mortality.	Describe the associations between SBT outcome (success/failure) and hospital mortality.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	Association between initial SBT outcome (success/failure) and ICU readmission.	Association between initial SBT outcome (success/failure) and ICU readmission (during the current hospitalization).	Through study completion (approximately 4 years)
Secondary	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; c) Describe the association between different SBT techniques on clinical outcomes and d) Describe the association between use of selected humidification strategies and clinical outcomes.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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).	Through study completion (approximately 4 years)
Secondary	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.	Through study completion (approximately 4 years)