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

• Incidence of post extubation minor complication [ 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
• Incidence of post extubation overall complication [ 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
• Incidence of 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.
• Incidence of Extubation failure [ Time Frame: Within 72 hours after extubation. ]
  Use of Non Invasive Ventilation to treat the failure or need of reintubation.
• Incidence of Reintubation [ Time Frame: Within 72 hours after extubation. ]
  Need of reintubation.

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.

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.

• Weaning Failure
• Mechanical Ventilation Complication

• 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.
• 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.

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

• 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.
• 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.

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

• 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