Clinical trial NCT06442930: EXtubation Related Complications - the EXTUBE Study (EXTUBE)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extubation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All 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 during the specified enrollment window

Brief summary: 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).

Detailed description: 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 determine the incidence of severe extubation-related complications within 60 minutes after extubation in adults who have undergone mechanical ventilation for general anesthesia or 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management
timeFrame: Within 60 minutes after the end of extubation
Secondary outcomes:
measure: Difficult airway and complications related to airway management if reintubation is required
timeFrame: Within 60 minutes after the end of extubation
measure: Planned and unplanned non-invasive respiratory support
timeFrame: Within 60 minutes after the end of extubation
measure: Emergency front of neck airway
timeFrame: Within 60 minutes after the end of extubation
measure: Cardiac arrhythmia requiring chemical or electrical treatment
timeFrame: Within 60 minutes after the end of extubation
measure: Severe Hypotension
timeFrame: Within 60 minutes after the end of extubation
measure: Severe Hypertension
timeFrame: Within 60 minutes after the end of extubation
measure: Pulmonary aspiration
timeFrame: Within 60 minutes after the end of extubation
measure: Barotrauma
timeFrame: Within 60 minutes after the end of extubation
measure: Dental injury
timeFrame: Within 60 minutes after the end of extubation
measure: Airways injury
timeFrame: Within 60 minutes after the end of extubation
measure: Mortality
timeFrame: Within 7 days after extubation
measure: Re-intubation
timeFrame: Within 48 hours after extubation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: UHN
name: Matteo Parotto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: