Clinical trial NCT03918811: Comparison of Two Extubation Techniques in Critically Ill Adult Patients
Official title: Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR Trial): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weaning Failure
Mechanical Ventilation Complication
Keywords: airway extubation
extubation methods
positive pressure
positive-pressure extubation
tracheal extubation
positive-pressure ventilation
extubation complications
Lead sponsor: Hospital Donación Francisco Santojanni
Sponsor class: OTHER
Collaborators: name: Matías Bertozzi
name: Marco Bezzi
name: Borello, Silvina, M.D.
name: Daniela Castro
name: Victoria Di Giorgio
name: Mariana Aguirre
name: Karina Miralles
name: Diego Noval
name: Sebastián Fredes
name: Eliana Wilhelm
name: Mauricio Zakimchuk
name: Julián Buffarini Cignoli
name: Mariana Bernardini
name: Leticia Rey
name: Valeria Pieroni
name: Pablo D´Annunzio
name: Gustavo Plotnikow
name: Romina Prato
name: Matías Lompizano
name: María Guaymas
name: Matías Accoce
name: Javier Dorado
name: Gimena Cardoso
name: Patricia Torres
name: Vanesa Pavlotsky
name: Emiliano Navarro
name: Eliana Markman
name: Paula Di Nardo
name: Ivonne Kunzi Steyer
name: Thomsen, Carolina, M.D.
name: Cecilia Palacios
name: Mariela Davies
name: Mercedes Ruffo
name: Victoria Leon
name: Fernando Tapia
First posted: 2019-04-18
Enrollment: 725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: superiority
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Major Post Extubation Complications
timeFrame: Within15 minutes after extubation.
Secondary outcomes:
measure: Number of Participants With Minor Post Extubation Complications
timeFrame: 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.
measure: Number of Participants With Overall Post Extubation Complications
timeFrame: 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.
measure: Number of Participants With Post Extubation Pneumonia
timeFrame: Within 72 hours after extubation.
measure: Number of Participants With Extubation Failure
timeFrame: Within 72 hours after extubation.
measure: Number of Participants That Required Reintubation
timeFrame: Within 72 hours after extubation.
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Santojanni
Study officials:
affiliation: Hospital Santojanni
name: Mauro F Andreu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
citation: Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, Garcia Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martin MC, Brovia CC, Pita MC, Pedace MP, De Benedetto MF, Delli Carpini J, Aguirre P, Montero G. Safety of Positive Pressure Extubation Technique. Respir Care. 2019 Aug;64(8):899-907. doi: 10.4187/respcare.06541. Epub 2019 Mar 26.