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Completed

NCT Number: NCT03955874

Mechanical Ventilation Discontinuation Practices

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

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Key information

Conditions

Invasive Mechanical Ventilation Critical Illness Direct Extubation Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Spontaneous Breathing Trial Tracheostomy Weaning Invasive Mechanical Ventilation

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton Health Sciences Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: IOS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 20, 2019
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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