Mechanical Ventilation Complication, Weaning Failure
Conditions
Keywords
airway extubation, extubation methods, positive pressure, positive-pressure extubation, tracheal extubation, positive-pressure ventilation, extubation complications
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.
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.
Interventions
PROCEDUREPositive 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.
PROCEDURETraditional 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.
Sponsors
Matías Bertozzi
Marco Bezzi
Borello, Silvina, M.D.
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
Thomsen, Carolina, M.D.
Cecilia Palacios
Mariela Davies
Mercedes Ruffo
Victoria Leon
Fernando Tapia
Hospital Donación Francisco Santojanni
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
Intervention model description
superiority
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Post Extubation Complications | Within15 minutes after extubation. | Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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 | 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 | Within 72 hours after extubation. | Use of Non Invasive Ventilation to treat the failure or need of reintubation. |
| Number of Participants That Required Reintubation | Within 72 hours after extubation. | Need of reintubation. |
Countries
Argentina
Participant flow
Recruitment details
Patients admitted to the ICU, Emergency Unit or Coronary Unit between April 1, 2019, and March 26, 2020, were included in the analysis. We included patients aged \> 18 years, requiring invasive mechanical ventilation through an ETT, who had successfully completed a spontaneous breathing trial and met the following OTE criteria: an adequate level of consciousness and effective cough (cough at order and/or at endotracheal suctioning). Informed consent was also required.
Pre-assignment details
Patients with a history of upper airway (UA) injury or surgery, with a limited therapeutic effort, who had previously been extubated or tracheostomized, or who had required noninvasive mechanical ventilation (NIMV) as a weaning method were excluded from our study. A total of 2567 patients met the eligibility criteria, 1842 were excluded from the study, and 725 were randomly assigned to the traditional extubation group (n=358) and positive pressure extubation group (n=367).
Participants by arm
| Arm | Count |
|---|---|
| Positive Pressure Extubation Technique ETT is removed in PSV 15/10 mode and without endotracheal suction.
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. | 367 |
| Traditional Extubation Technique ETT is removed with continuous endotracheal suction
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. | 358 |
| Total | 725 |
Baseline characteristics
| Characteristic | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 164 Participants | 155 Participants | 319 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants | 203 Participants | 406 Participants |
| Age, Continuous | 64 years | 63 years | 63 years |
| High Risk of Extubation Failure | 302 Participants | 295 Participants | 597 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 367 Participants | 358 Participants | 725 Participants |
| Region of Enrollment Argentina | 367 participants | 358 participants | 725 participants |
| Sex: Female, Male Female | 146 Participants | 134 Participants | 280 Participants |
| Sex: Female, Male Male | 221 Participants | 224 Participants | 445 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 41 / 363 | 45 / 345 |
| other Total, other adverse events | 0 / 363 | 0 / 345 |
| serious Total, serious adverse events | 0 / 363 | 0 / 345 |
Outcome results
Primary
Number of Participants With Major Post Extubation Complications
Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
Time frame: Within15 minutes after extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants With Major Post Extubation Complications | 89 Participants |
| Traditional Extubation Technique | Number of Participants With Major Post Extubation Complications | 96 Participants |
Secondary
Number of Participants That Required Reintubation
Need of reintubation.
Time frame: Within 72 hours after extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants That Required Reintubation | 44 Participants |
| Traditional Extubation Technique | Number of Participants That Required Reintubation | 51 Participants |
Secondary
Number of Participants With Extubation Failure
Use of Non Invasive Ventilation to treat the failure or need of reintubation.
Time frame: Within 72 hours after extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants With Extubation Failure | 48 Participants |
| Traditional Extubation Technique | Number of Participants With Extubation Failure | 61 Participants |
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants With Minor Post Extubation Complications | 144 Participants |
| Traditional Extubation Technique | Number of Participants With Minor Post Extubation Complications | 156 Participants |
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants With Overall Post Extubation Complications | 190 Participants |
| Traditional Extubation Technique | Number of Participants With Overall Post Extubation Complications | 197 Participants |
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.
Time frame: Within 72 hours after extubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Positive Pressure Extubation Technique | Number of Participants With Post Extubation Pneumonia | 18 Participants |
| Traditional Extubation Technique | Number of Participants With Post Extubation Pneumonia | 24 Participants |