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

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

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.

Study Overview

• Status: Terminated
• Conditions: Mechanical Ventilation Complication; Weaning Failure
• Intervention / Treatment: Procedure: Positive Pressure Extubation Technique; Procedure: Traditional Extubation Technique

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.

• Study Type: Interventional
• Enrollment (Actual): 725
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1408
    • Hospital Santojanni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Positive Pressure Extubation Technique; ETT is removed in PSV 15/10 mode and without endotracheal suction.	Procedure: Positive Pressure Extubation Technique; 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.
Active Comparator: Traditional Extubation Technique; ETT is removed with continuous endotracheal suction	Procedure: Traditional Extubation Technique; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hospital Donación Francisco Santojanni
• Collaborators: Matías Bertozzi; Marco Bezzi; Silvina Borello; Daniela Castro; Victoria Di Giorgio; Mariana Aguirre; Karina Miralles; Diego Noval; Sebastián Fredes; Eliana Wilhelm; Mauricio Zakimchuk; Julián Buffarini Cignoli; Mariana Bernardini; Leticia Rey; Valeria Pieroni; Pablo D´Annunzio; Gustavo Plotnikow; Romina Prato; Matías Lompizano; María Guaymas; Matías Accoce; Javier Dorado; Gimena Cardoso; Patricia Torres; Vanesa Pavlotsky; Emiliano Navarro; Eliana Markman; Paula Di Nardo; Ivonne Kunzi Steyer; Carolina Thomsen; Cecilia Palacios; Mariela Davies; Mercedes Ruffo; Victoria Leon; Fernando Tapia
• Investigators: Principal Investigator: Mauro F Andreu, Prof, Hospital Santojanni

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: airway extubation; tracheal extubation; extubation methods; positive pressure; positive-pressure extubation; positive-pressure ventilation; extubation complications
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 12-2018-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No