Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR)

Hospital Donación Francisco Santojanni

Status: Terminated

Conditions: Weaning Failure; Mechanical Ventilation Complication

Treatments: Procedure: Traditional Extubation Technique; Procedure: Positive Pressure Extubation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03918811

12-2018-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 725 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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725 participants in 2 patient groups

Positive Pressure Extubation Technique

Experimental group

Description:

ETT is removed in PSV 15/10 mode and without endotracheal suction.

Treatment:

Procedure: Positive Pressure Extubation Technique

Traditional Extubation Technique

Active Comparator group

Description:

ETT is removed with continuous endotracheal suction

Treatment:

Procedure: Traditional Extubation Technique