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Mechanical Ventilation Discontinuation Practices (IOS)

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ClinicalTrials.gov Identifier: NCT03955874
Recruitment Status : Completed
First Posted : May 20, 2019
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

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


Condition or disease
Invasive Mechanical Ventilation Critical Illness Spontaneous Breathing Trial Weaning Invasive Mechanical Ventilation Tracheostomy Direct Extubation

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

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Study Type : Observational
Actual Enrollment : 1868 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Practice Pattern Variation in Discontinuing Mechanical Ventilation in Critically Ill Adults: An International Prospective Observational Study
Actual Study Start Date : November 4, 2013
Actual Primary Completion Date : December 17, 2016
Actual Study Completion Date : December 17, 2016

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.)

  5. 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)

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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.


Secondary Outcome Measures :
  1. 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) ]
    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)

  2. Association between initial SBT outcome (success/failure) and total duration of ventilation. [ Time Frame: Through study completion (approximately 4 years) ]
    Describe the associations between SBT outcome (success/failure) and the total duration of ventilation.

  3. Association between initial SBT outcome (success/failure) and ICU mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Describe the associations between SBT outcome (success/failure) and ICU mortality.

  4. Association between initial SBT outcome (success/failure) and hospital mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Describe the associations between SBT outcome (success/failure) and hospital mortality.

  5. 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) ]
    Describe the associations between SBT outcome (success/failure) and the proportion of patients off the ventilator at day 28.

  6. 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) ]
    Describe the associations between SBT outcome (success/failure) and the proportion of patients out of the ICU at day 28.

  7. Association between initial SBT outcome (success/failure) and ICU LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    Describe the associations between SBT outcome (success/failure) and ICU LOS (total and among survivors and non survivors.

  8. Association between initial SBT outcome (success/failure) and hospital LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    Describe the associations between SBT outcome (success/failure) and hospital LOS (total and among survivors and non survivors.

  9. 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 ICU readmission (during the current hospitalization).

  10. Association between initial SBT outcome (success/failure) and reintubation. [ Time Frame: Through study completion (approximately 4 years) ]

    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.


  11. 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) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the total duration of ventilation.

  12. 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) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU mortality.

  13. 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) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital mortality.

  14. 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) ]
    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.

  15. 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) ]
    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.

  16. 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) ]
    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).

  17. 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) ]
    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).

  18. 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) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU readmission (during the current hospitalization).

  19. 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) ]
    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.

  20. Association between different SBT techniques and total duration of ventilation. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on the total duration of ventilation.

  21. Association between different SBT techniques and ICU mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU mortality.

  22. Association between different SBT techniques and hospital mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on hospital mortality.

  23. Association between different SBT techniques and the proportion of patients off the ventilator at day 28. [ Time Frame: Through study completion (approximately 4 years) ]
    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.

  24. 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) ]
    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.

  25. Association between different SBT techniques and ICU LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    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).

  26. Association between different SBT techniques and hospital LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    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).

  27. Association between different SBT techniques and ICU readmission. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different SBT technique (e.g., Pressure Support, T-piece) and the impact on ICU readmission (during the current hospitalization).

  28. Association between different SBT techniques and reintubation. [ Time Frame: Through study completion (approximately 4 years) ]
    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

  29. Association between use of selected humidification strategies and the total duration of ventilation. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on the total duration of ventilation.

  30. Association between use of selected humidification strategies and ICU mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on ICU mortality.

  31. Association between use of selected humidification strategies and hospital mortality. [ Time Frame: Through study completion (approximately 4 years) ]
    Associations between use of different humidification strategies (e.g., Heat and Moisture Exchanger, heated humidifier) and the impact on hospital mortality.

  32. 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) ]
    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.

  33. 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) ]
    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.

  34. Association between use of selected humidification strategies and ICU LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    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).

  35. Association between use of selected humidification strategies and hospital LOS. [ Time Frame: Through study completion (approximately 4 years) ]
    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).

  36. Association between use of selected humidification strategies and ICU readmission. [ Time Frame: Through study completion (approximately 4 years) ]
    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).

  37. Association between use of selected humidification strategies and reintubation. [ Time Frame: Through study completion (approximately 4 years) ]
    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.


Other Outcome Measures:
  1. Predictors of initial SBT outcome. [ Time Frame: Through study completion (approximately 4 years) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955874


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Canada, Ontario
Hamilton Health Sciences Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Juravinski Hospital Cancer Centre
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre - University Hospital Campus
London, Ontario, Canada, N6A 5A5
Ottawa Civic Hospital
Ottawa, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Saint-Luc
Montréal, Quebec, Canada, H2X 3J4
Universite de Sherbrooke
Sherbrooke, Quebec, Canada
Universite Hopitalier de Sherbrooke
Sherbrooke, Quebec, Canada
Ciusss McQ
Trois-Rivières, Quebec, Canada, G9A5C5
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Karen E.A. Burns, MD, FRCPC, MSc St. Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03955874    
Other Study ID Numbers: 11-024
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Pathologic Processes
Disease Attributes