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NCT06442930Recruiting

EXtubation Related Complications - the EXTUBE Study (EXTUBE)

University Health Network, Toronto

Start Date

4/14/2025

Completion Date

12/1/2027

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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Extubation

Locations

Banner University Medical Centre

Tucson, Arizona 85724-5114

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205

United States

University of Florida

Gainesville, Florida 32608

United States

The University of Chicago

Chicago, Illinois 60637

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

The University of Texas Health Science Center

Houston, Texas 77030

United States

Royal North Shore Hospital

Sydney, New South Wales 2065

Australia

The Northern Hospital

Melbourne, Victoria 3076

Australia

Austin Hospital

Melbourne, Victoria 3084

Australia

Eastern Health - Box Hill Hospital

Melbourne, Victoria 3128

Australia

Eastern Health - Maroondah Hospital

Melbourne, Victoria 3135

Australia

Eastern Health - Angliss Hospital

Melbourne, Victoria 3156

Australia

Surrey Memorial Hospital

Surrey, British Columbia V3V 1Z2

Canada

The Moncton Hospital

Moncton, New Brunswick E1C 4B7

Canada

Sunnybrook Hospital

North York, Ontario M4N 3M5

Canada

Niagara Health - Marotta Family Hospital

Saint Catharines, Ontario L2S 0A9

Canada

St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5

Canada

University Health Network - Toronto General Hospital

Toronto, Ontario M5G 2C4

Canada

University Health Network - Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec H2X 0C1

Canada

Hospital Internacional de Colombia

Piedecuesta,

Colombia

Mayo University Hospital

Castlebar, F23 H529

Ireland

Cork University Hospital

Cork, T12 DFK4

Ireland

Mater Misericordiae University Hospital

Dublin, D07 R2WY

Ireland

Galway University Hospitals

Galway, H91 YR71

Ireland

University Hospital Waterford

Waterford, X91 ER8E

Ireland

Southland Hospital

Invercargill, 9812

New Zealand

Rotorua Hospital

Rotorua, 3010

New Zealand

Tan Tock Seng Hospital

Singapore, 308433

Singapore

Royal United Hospitals Bath

Bath, BA1 3NG

United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom