Comparison of Two Extubation Techniques in Critically Ill Adult Patients

NCT03918811 | Terminated Results

• 1 other identifier: 12-2018-05
• Study Type: interventional
• Target: 725
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure; Mechanical Ventilation Complication

Keywords

airway extubation; extubation methods; positive pressure; positive-pressure extubation; tracheal extubation; positive-pressure ventilation; extubation complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants With Minor Post Extubation Complications

  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

  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

  Within 72 hours after extubation.

• Number of Participants With Extubation Failure

  Within 72 hours after extubation.

• Number of Participants That Required Reintubation

  Within 72 hours after extubation.

Study Arms (2)

Positive Pressure Extubation Technique

EXPERIMENTAL

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

Procedure: Positive Pressure Extubation Technique

Traditional Extubation Technique

ACTIVE COMPARATOR

ETT is removed with continuous endotracheal suction

Procedure: Traditional Extubation Technique

Interventions

Positive Pressure Extubation Technique PROCEDURE

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.

Positive Pressure Extubation Technique

Traditional Extubation Technique PROCEDURE

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.

Traditional Extubation Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of upper airway injury or surgery
• Previously extubated or tracheostomized
• Noninvasive ventilation (NIV) as a weaning method
• Decision to not reanimate

Sponsors & Collaborators

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

Study Sites (1)

Hospital Santojanni

Buenos Aires, 1408, Argentina

Location

Related Publications (2)

• 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.

  PMID: 25425709 BACKGROUND

• 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.

  PMID: 30914493 BACKGROUND

Results Point of Contact

• Title: Professor Mauro Andreu
• Organization: Hospitalsantojanni

mfandreu@gmail.com

+541168788298

Study Officials

• Mauro F Andreu, Prof

  Hospital Santojanni

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: superiority

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 18, 2019
• Study Start: April 1, 2019
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)