Comparison of Two Extubation Techniques in Critically Ill Adult Patients

Mechanical Ventilation Complication Clinical Trial

— ExtubAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03918811
• Other study ID #: 12-2018-05
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: January 2021
• Source: Hospital Donación Francisco Santojanni
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 725
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication
• Weaning Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Hospital Santojanni	Buenos Aires

Sponsors (36)

Lead Sponsor

Collaborator

Hospital Donación Francisco Santojanni

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

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, García Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martín 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. — View Citation

Andreu MF, Salvati IG, Donnianni MC, Ibañez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Number of Participants With Extubation Failure	Use of Non Invasive Ventilation to treat the failure or need of reintubation.	Within 72 hours after extubation.
Secondary	Number of Participants That Required Reintubation	Need of reintubation.	Within 72 hours after extubation.