An interventional study of Positive Pressure Extubation Technique and Traditional Extubation Technique in Weaning Failure and Mechanical Ventilation Complication, sponsored by Hospital Donación Francisco Santojanni. Terminated at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Hospital Donación Francisco Santojanni · Not applicable, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 725 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Hospital Donación Francisco Santojanni is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ETT is removed in PSV 15/10 mode and without endotracheal suction.
Procedure: Positive Pressure Extubation Technique
ETT is removed with continuous endotracheal suction
Procedure: Traditional 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 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.
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.
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.
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.
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.
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.
Number of Participants That Required Reintubation
Need of reintubation.
Time frame: Within 72 hours after extubation.
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.
| Milestone | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Started | 367 | 358 |
| Completed | 363 | 345 |
| Not completed | 4 | 13 |
Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants With Major Post Extubation Complications | 89 | 96 |
Clinical evidence of at least one of the following: * Hypertension * Tachycardia * Tachypnea * Poor respiratory mechanics * Bronchospasm * Severe cough * Post obstructive pulmonary edema
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants With Minor Post Extubation Complications | 144 | 156 |
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
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants With Overall Post Extubation Complications | 190 | 197 |
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.
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants With Post Extubation Pneumonia | 18 | 24 |
Use of Non Invasive Ventilation to treat the failure or need of reintubation.
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants With Extubation Failure | 48 | 61 |
Need of reintubation.
| Participants | Positive Pressure Extubation Technique | Traditional Extubation Technique |
|---|---|---|
| Number of Participants That Required Reintubation | 44 | 51 |
Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positive Pressure Extubation Technique | 41/363 (11.3%) | 0/363 (0%) | 0/363 (0%) |
| Traditional Extubation Technique | 45/345 (13%) | 0/345 (0%) | 0/345 (0%) |
| Age, Categorical(Participants) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 203 | 203 | 406 |
| >=65 years | 164 | 155 | 319 |
| Age, Continuous(years) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| Median | 64 (52 to 74) | 63 (51 to 73) | 63 (51 to 74) |
| Sex: Female, Male(Participants) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| Female | 146 | 134 | 280 |
| Male | 221 | 224 | 445 |
| Race (NIH/OMB)(Participants) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 367 | 358 | 725 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| Argentina | 367 | 358 | 725 |
| High Risk of Extubation Failure(Participants) | Positive Pressure Extubation Technique | Traditional Extubation Technique | Total |
|---|---|---|---|
| Count of participants | 302 | 295 | 597 |
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Hospital Donación Francisco Santojanni