Mechanical Ventilation Discontinuation Practices

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INITIAL SBT<br>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<br>Patients that were directly extubated without conduct of a prior SBT or tracheostomy | |
| DIRECT TRACHEOSTOMY<br>Patients who underwent a direct tracheostomy without conduct of a prior SBT or extubation | |
| No attempt at mechanical ventilation discontinuation<br>Patients who died without conduct of a prior SBT, extubation or tracheostomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |