EXtubation Related Complications - the EXTUBE Study (EXTUBE)

Extubation Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06442930
• Other study ID #: 23-5794
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Extubation

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