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临床试验/NCT06442930
NCT06442930招募中不适用

EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study

University Health Network, Toronto35 个研究点 分布在 9 个国家目标入组 3,000 人开始时间: 2025年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
35
主要终点
At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management

研究概览

简要总结

EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).

详细描述

Globally, over 200 million people each year require extubation. While routinely performed, extubation is a skilled and potentially high-risk procedure that should be performed only when physiologic, pharmacologic, and contextual conditions are optimal. Complications at this stage of patient care can result in decreased oxygen delivery to the brain and body, sometimes leading to serious adverse events such as cardiac arrest, brain damage, or death. Indeed, one quarter of airway complications that result in death or brain death occur at the time of extubation.

Despite the frequency of extubation and the potential for life-threatening complications, there is a lack of systematic data on the rate and circumstances under which these severe complications occur. The limited data indicate 10-30% of extubations may lead to severe complications, depending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, mostly single-center, based on clinician recall, only capture a small portion of extubation complications (e.g., malpractice claims), or do not reflect current clinical practice. In addition, most lack a denominator and exclude successful extubations, making estimates of actual complication rates and risk factors impossible.

There has been no large study of extubation techniques or adherence to guidelines, so procedural factors associated with complications must be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys show non-adherence to some best practices and considerable variation in practice, and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes, with half of the complications deemed preventable. Therefore, data on the frequency and nature of extubation complications, patient and procedural risk factors for complications, and guideline adherence rates are needed before these preventable events can be addressed.

EXTUBE (EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit) is an international, multicenter, prospective cohort study

The primary objective of this study is to estimate the incidence of immediate complications related to extubation in adult patients after general anesthesia and/or after critical illness. The secondary objectives are to determine: 1) the incidence of mild extubation complications; 2) patient- and procedure-related risk factors for extubation complications; 3) the association between extubation complications and outcomes until hospital discharge; and 4) the rate of adherence to extubation clinical practice guidelines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (≥18 years old)
  • •Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU
  • •Undergoing extubation during the specified enrollment window

排除标准

  • •Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
  • •Patients will be excluded if the extubation is performed for tracheostomy decannulation
  • •For each patient who is not included, reasons for exclusion will be reported.

结局指标

主要结局

At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management

时间窗: Within 60 minutes after the end of extubation

The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation: i) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \< 80% for \> 5 minutes) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).

At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management

时间窗: Within 60 minutes after the end of extubation

The primary outcome will be the occurrence of at least one of the following (composite outcome) occurring within 60 minutes after the end of extubation: i) Severe hypoxemia (oxygen saturation as measured by pulse oximetry falls below SpO2 \< 80% for \> 5 minutes) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).

次要结局

  • Re-intubation(Within 48 hours after extubation)
  • Difficult airway and complications related to airway management if reintubation is required(Within 60 minutes after the end of extubation)
  • Pulmonary aspiration(Within 60 minutes after the end of extubation)
  • Mortality(Within 7 days after extubation)
  • Planned and unplanned non-invasive respiratory support(Within 60 minutes after the end of extubation)
  • Emergency front of neck airway(Within 60 minutes after the end of extubation)
  • Cardiac arrhythmia requiring chemical or electrical treatment(Within 60 minutes after the end of extubation)
  • Severe Hypotension(Within 60 minutes after the end of extubation)
  • Dental injury(Within 60 minutes after the end of extubation)
  • Severe Hypertension(Within 60 minutes after the end of extubation)
  • Barotrauma(Within 60 minutes after the end of extubation)
  • Airways injury(Within 60 minutes after the end of extubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (35)

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