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

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ClinicalTrials.gov Identifier: NCT03918811
Recruitment Status : Terminated (Due to the outbreak of the SARS-CoV-2 pandemic in Argentina and the lack of information about the potential risks of contamination from extubation and aerosolization, we stopped recruiting patients before achieving the predefined sample size.)
First Posted : April 18, 2019
Results First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
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
Information provided by (Responsible Party):
Mauro Andreu, Hospital Donación Francisco Santojanni

Study Description
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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.


Condition or disease Intervention/treatment Phase
Weaning Failure Mechanical Ventilation Complication Procedure: Positive Pressure Extubation Technique Procedure: Traditional Extubation Technique Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 725 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: superiority
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Due to the nature of the intervention, blinding of the subject and the operators responsible for extubation is not possible. The person in charge of data statistical analysis and the evaluator who assess and record outcome measures will be blinded to the allocated intervention.
Primary Purpose: Treatment
Official Title: Comparison of Two Extubation Techniques in Critically Ill Adult Patients (ExtubAR Trial): Randomized Clinical Trial
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : March 26, 2020
Actual Study Completion Date : March 26, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Major Post Extubation Complications [ Time Frame: Within15 minutes after extubation. ]

    Clinical evidence of at least one of the following:

    • Upper airway obstruction
    • Desaturation
    • Vomiting


Secondary Outcome Measures :
  1. Number of Participants With Minor Post Extubation Complications [ 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. ]

    Clinical evidence of at least one of the following:

    • Hypertension
    • Tachycardia
    • Tachypnea
    • Poor respiratory mechanics
    • Bronchospasm
    • Severe cough
    • Post obstructive pulmonary edema

  2. Number of Participants With Overall Post Extubation Complications [ 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. ]

    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

  3. Number of Participants With Post Extubation Pneumonia [ Time Frame: Within 72 hours after extubation. ]
    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.

  4. Number of Participants With Extubation Failure [ Time Frame: Within 72 hours after extubation. ]
    Use of Non Invasive Ventilation to treat the failure or need of reintubation.

  5. Number of Participants That Required Reintubation [ Time Frame: Within 72 hours after extubation. ]
    Need of reintubation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918811


Locations
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Argentina
Hospital Santojanni
Buenos Aires, Argentina, 1408
Sponsors and Collaborators
Hospital Donación Francisco Santojanni
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
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Principal Investigator: Mauro F Andreu, Prof Hospital Santojanni
  Study Documents (Full-Text)

Documents provided by Mauro Andreu, Hospital Donación Francisco Santojanni:
Study Protocol and Statistical Analysis Plan  [PDF] February 28, 2019

More Information
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Publications:

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Responsible Party: Mauro Andreu, Physical Therapist, Hospital Donación Francisco Santojanni
ClinicalTrials.gov Identifier: NCT03918811    
Other Study ID Numbers: 12-2018-05
First Posted: April 18, 2019    Key Record Dates
Results First Posted: February 9, 2021
Last Update Posted: February 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Andreu, Hospital Donación Francisco Santojanni:
airway extubation
extubation methods
positive pressure
positive-pressure extubation
 tracheal extubation
positive-pressure ventilation
extubation complications
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes