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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
725
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.
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.
Hospital Santojanni
Buenos Aires, Argentina
Number of Participants With Major Post Extubation Complications
Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
Time frame: Within15 minutes after extubation.
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
Time frame: 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
Time frame: 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.
Time frame: Within 72 hours after extubation.
Number of Participants With Extubation Failure
Use of Non Invasive Ventilation to treat the failure or need of reintubation.
Time frame: Within 72 hours after extubation.
Number of Participants That Required Reintubation
Need of reintubation.
Time frame: Within 72 hours after extubation.
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