Comparison of Two Extubation Techniques in Critically Ill Adult Patients

Not Applicable

Terminated

Conditions: Weaning Failure
Mechanical Ventilation Complication

Interventions: Procedure: Traditional Extubation Technique
Procedure: Positive Pressure Extubation Technique

Registration Number: NCT03918811

Lead Sponsor: Hospital Donación Francisco Santojanni

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 725

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Extubation Technique	Traditional Extubation Technique	ETT is removed with continuous endotracheal suction
Positive Pressure Extubation Technique	Positive Pressure Extubation Technique	ETT is removed in PSV 15/10 mode and without endotracheal suction.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Post Extubation Complications	Within15 minutes after extubation.	Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Minor Post Extubation Complications	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.	Clinical evidence of at least one of the following: * Hypertension * Tachycardia * Tachypnea * Poor respiratory mechanics * Bronchospasm * Severe cough * Post obstructive pulmonary edema
Number of Participants With Overall Post Extubation Complications	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.	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
Number of Participants With Extubation Failure	Within 72 hours after extubation.	Use of Non Invasive Ventilation to treat the failure or need of reintubation.
Number of Participants With Post Extubation Pneumonia	Within 72 hours after extubation.	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.
Number of Participants That Required Reintubation	Within 72 hours after extubation.	Need of reintubation.