Comparison of Two Extubation Techniques in Critically Ill Adult Patients

Study Overview
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Brief Summary
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Orotracheal extubation consists in the removal of the endotracheal tube (ETT) when it is no longer required. This procedure may carry a considerable risk of complications and extubation failure. The literature points out two methods of extubation: the traditional method and the positive pressure method. In a noninferiority clinical trial it was demonstrated that EOT with positive pressure and without endotracheal suction was a safe technique and could be better than traditional extubation. Although prior studies reported better clinical outcomes with the positive pressure extubation technique, its superiority has not been deeply studied yet. Therefore, the objective of our study is to determine whether the positive pressure OTE technique, compared with the traditional OTE technique, reduces the incidence of major postextubation complications (up to 60 minutes) in critically ill adult patients.

Detailed Description
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Design: Multicenter randomized controlled clinical trial Methods: Critically ill adult subjects on invasive mechanical ventilation who met extubation criteria will be included. Will be randomly assigned to positive-pressure extubation (n=389) or to traditional extubation (n=389). The main variable will be incidence of major complications.

Official Title
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Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR Trial): Randomized Clinical Trial

Conditions
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Weaning Failure, Mechanical Ventilation Complication

Intervention / Treatment
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* Procedure: Positive Pressure Extubation Technique
* Procedure: Traditional Extubation Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 Invasive mechanical ventilation through an endotracheal tube, Successfully complete a spontaneous breathing trial Adequate level of consciousness (Glasgow Coma Score >8) Effective cough. Written informed consent from a relative or legal representative. Exclusion Criteria: History of upper airway injury or surgery Previously extubated or tracheostomized Noninvasive ventilation (NIV) as a weaning method Decision to not reanimate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: superiority
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Pressure Extubation Technique<br>ETT is removed in PSV 15/10 mode and without endotracheal suction. | Procedure: Positive Pressure Extubation Technique<br>* Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx.<br>|
| Active Comparator: Traditional Extubation Technique<br>ETT is removed with continuous endotracheal suction | Procedure: Traditional Extubation Technique<br>* Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Post Extubation Complications | Clinical evidence of at least one of the following: Upper airway obstruction Desaturation Vomiting | Within15 minutes after extubation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Minor Post Extubation Complications | Clinical evidence of at least one of the following: Hypertension Tachycardia Tachypnea Poor respiratory mechanics Bronchospasm Severe cough Post obstructive pulmonary edema | Hypertension, Tachycardia, Tachypnea or Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. | 
| Number of Participants With Overall Post Extubation Complications | Clinical evidence of at least one of the following: Upper airway obstruction Desaturation Vomiting Hypertension Tachycardia Tachypnea Poor respiratory mechanics Bronchospasm Severe cough Post obstructive pulmonary edema | Upper airway obstruction, Desaturation, Vomiting, Hypertension, Tachycardia, Tachypnea, Poor Respiratory Mechanics, within 15 minutes after extubation. Bronchospasm, Severe cough or Post Obstructive Pulmonary Edema, within 60 minutes after extubation. | 
| Number of Participants With Post Extubation Pneumonia | Presence of a new radiographic infiltrate or progression of infiltrates prior to extubation and any of the following: fever, leukocytosis (greater than 10,000 / mm3) or leukopenia (less than 4,000 / mm3) compared to the value prior to extubation and increase in the amount or change in the quality of tracheobronchial secretions. | Within 72 hours after extubation. | 
| Number of Participants With Extubation Failure | Use of Non Invasive Ventilation to treat the failure or need of reintubation. | Within 72 hours after extubation. | 
| Number of Participants That Required Reintubation | Need of reintubation. | Within 72 hours after extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extubation methods, airway extubation, positive pressure, positive-pressure extubation, tracheal extubation, positive-pressure ventilation, extubation complications