Mechanical Ventilation Discontinuation Practices (IOS)
2021年3月30日 更新者：Unity Health Toronto
Practice Pattern Variation in Discontinuing Mechanical Ventilation in Critically Ill Adults: An International Prospective Observational Study
Background: The requirement for ventilator support is a defining feature of critical illness. Weaning is the process during which the work of breathing is transferred from the ventilator back to the patient. Approximately 40% of the total time spent on ventilators is dedicated to weaning. The extent of practice variation in how this complex and expensive technology is discontinued from critically ill patients is unknown. Meanwhile, practice variation has been shown to adversely impact upon patient safety and clinical outcomes.
Purpose: To characterize practice pattern variation in weaning and the consequences of weaning variation by implementing an international, prospective observational study in Canada, the United States, the United Kingdom, Europe, India and Australia/New Zealand.
Primary Objectives: To describe
- weaning practice variation among regions in 5 domains (the use of daily screening, preferred methods of support used before initial discontinuation attempts, use of written protocols, preferred methods of evaluating spontaneous breathing, and sedation and mobilization practices).
- the assocation between selected discontinuation strategies and important clinical outcomes (length of stay, mortality, duration of ventilation).
Methods: The investigators propose to conduct a large scale, observational study involving critically ill adults requiring ventilator support for at least 24 hours to evaluate practices in discontinuing ventilators in 150 centres. The investigators will classify each new admission over the observation period according to the initial strategy that precipitated or facilitated ventilator discontinuation.
Relevance: This novel study will build collaborations with critical care investigators from around the world and industry
研究概览
详细说明
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
研究类型
观察性的
注册 (实际的)
1868
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ontario
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Hamilton、Ontario、加拿大
- St. Joseph's Hospital
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Hamilton、Ontario、加拿大、L8L2X2
- Hamilton Health Sciences Hamilton General Hospital
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Hamilton、Ontario、加拿大
- Juravinski Hospital Cancer Centre
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London、Ontario、加拿大、N6A 5A5
- London Health Sciences Centre - University Hospital Campus
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Ottawa、Ontario、加拿大
- Ottawa Civic Hospital
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Ottawa、Ontario、加拿大
- Ottawa General Hospital
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael's Hospital
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Toronto、Ontario、加拿大
- Mount Sinai Hospital
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Quebec
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Montréal、Quebec、加拿大、H2X 3J4
- Hôpital Saint-Luc
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Sherbrooke、Quebec、加拿大
- Université de Sherbrooke
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Sherbrooke、Quebec、加拿大
- Universite Hopitalier de Sherbrooke
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Trois-Rivières、Quebec、加拿大、G9A5C5
- Ciusss McQ
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-
-
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Health System
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
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
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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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.
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DIRECT EXTUBATION
Patients that were directly extubated without conduct of a prior SBT or tracheostomy
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DIRECT TRACHEOSTOMY
Patients who underwent a direct tracheostomy without conduct of a prior SBT or extubation
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No attempt at mechanical ventilation discontinuation
Patients who died without conduct of a prior SBT, extubation or tracheostomy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Practice variation among geographic regions in the use of daily screening to identify candidates to undergo an SBT
大体时间：Through study completion (approximately 4 years)
|
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
大体时间：Through study completion (approximately 4 years)
|
Differences in ventilator modes (Pressure Support, Assist Control, other) prior to discontinuation attempts
|
Through study completion (approximately 4 years)
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Practice variation among geographic regions in the use of written weaning and SBT protocols
大体时间：Through study completion (approximately 4 years)
|
Use of written protocols to liberate patients from ventilators
|
Through study completion (approximately 4 years)
|
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Practice variation among geographic regions in the methods used to conduct SBTs (and humidify oxygen)
大体时间：Through study completion (approximately 4 years)
|
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
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：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.
|
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.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between variation in the weaning practices and ICU LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between variation in the weaning practices and hospital LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between variation in the weaning practices and ICU readmission.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：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.
|
Through study completion (approximately 4 years)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Identify baseline characteristics and time-dependent factors associated with use of selected strategy (direct extubation, direct tracheostomy, Initial SBT) to discontinue mechanical ventilation
大体时间：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)
|
Through study completion (approximately 4 years)
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Association between initial SBT outcome (success/failure) and total duration of ventilation.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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
大体时间：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.
|
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.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between initial SBT outcome (success/failure) and ICU LOS.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：Through study completion (approximately 4 years)
|
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.
大体时间：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. |
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.
大体时间：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.
|
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.
大体时间：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.
|
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.
大体时间：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.
|
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.
大体时间：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.
|
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.
大体时间：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.
|
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.
大体时间：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).
|
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.
大体时间：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).
|
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.
大体时间：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).
|
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.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and total duration of ventilation.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and ICU mortality.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and hospital mortality.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and the proportion of patients off the ventilator at day 28.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and the proportion of patients out of the ICU at day 28.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and ICU LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and hospital LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and ICU readmission.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between different SBT techniques and reintubation.
大体时间：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
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and the total duration of ventilation.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and ICU mortality.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and hospital mortality.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and the proportion of patients off the ventilator at day 28.
大体时间：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.
|
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.
大体时间：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.
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and ICU LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and hospital LOS.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and ICU readmission.
大体时间：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).
|
Through study completion (approximately 4 years)
|
|
Association between use of selected humidification strategies and reintubation.
大体时间：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.
|
Through study completion (approximately 4 years)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Predictors of initial SBT outcome.
大体时间：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.
|
Through study completion (approximately 4 years)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Karen E.A. Burns, MD, FRCPC, MSc、St. Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- Burns KEA, Rizvi L, Cook DJ, Dodek P, Slutsky AS, Jones A, Villar J, Kapadia FN, Gattas DJ, Epstein SK, Meade MO; Canadian Critical Care Trials Group. Variation in the practice of discontinuing mechanical ventilation in critically ill adults: study protocol for an international prospective observational study. BMJ Open. 2019 Sep 8;9(9):e031775. doi: 10.1136/bmjopen-2019-031775.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月4日
初级完成 (实际的)
2016年12月17日
研究完成 (实际的)
2016年12月17日
研究注册日期
首次提交
2019年5月3日
首先提交符合 QC 标准的
2019年5月16日
首次发布 (实际的)
2019年5月20日
研究记录更新
最后更新发布 (实际的)
2021年4月2日
上次提交的符合 QC 标准的更新
2021年3月30日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.