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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06442930
Other study ID # 23-5794
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2024
Est. completion date December 2025

Study information

Verified date June 2024
Source University Health Network, Toronto
Contact Matteo Parotto, MD, PhD
Phone +1 416 340 3567
Email matteo.parotto@uhn.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 - Patients will be excluded if the extubation is accidental. For each patient who is not included, reasons for exclusion will be reported.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management 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%) ii) Cardiac arrest iii) Need for airway management (reintubation, insertion of a supraglottic airway, bag-mask ventilation).
Within 60 minutes after the end of extubation
Secondary Difficult airway if reintubation is required Difficult airway (i.e., anticipated or experienced difficulty by an experienced airway manager with any or all of laryngoscopy or tracheal intubation, supraglottic airway use, face-mask ventilation, or front-of-neck airway) if reintubation is required Within 60 minutes after the end of extubation
Secondary Complications related to airway management if reintubation is required Complications related to airway management (e.g., oesophageal intubation) if reintubation is required Within 60 minutes after the end of extubation
Secondary Unplanned non-invasive respiratory support Unplanned non-invasive respiratory support Within 60 minutes after the end of extubation
Secondary Emergency front of neck airway Emergency front of neck airway should airway management be required after extubation Within 60 minutes after the end of extubation
Secondary Cardiac arrhythmia requiring chemical or electrical treatment Cardiac arrhythmia requiring chemical or electrical treatment Within 60 minutes after the end of extubation
Secondary Hypotension Hypotension (systolic arterial pressure < 65 mmHg recorded at any time or < 90 mmHg for >30 minutes) Within 60 minutes after the end of extubation
Secondary Hypertension Severe hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =120 mmHg) Within 60 minutes after the end of extubation
Secondary Pulmonary aspiration Aspiration of gastric contents (gastric contents inhaled into the larynx and the respiratory tract) Within 60 minutes after the end of extubation
Secondary Barotrauma Pneumothorax/pneumo-mediastinum Within 60 minutes after the end of extubation
Secondary Dental injury Dental injury (notable change to the patient's dentition attributable to extubation or to reintubation, should this be required) Within 60 minutes after the end of extubation
Secondary Mortality In-hospital mortality Within 7 days after extubation
Secondary Re-intubation Re-intubation within 48 hours of extubation Within 48 hours after extubation
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