Trial Outcomes & Findings for Comparison of Two Extubation Techniques in Critically Ill Adult Patients (NCT NCT03918811)
NCT ID: NCT03918811
Last Updated: 2021-02-09
Results Overview
Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
725 participants
Primary outcome timeframe
Within15 minutes after extubation.
Results posted on
2021-02-09
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
367
|
358
|
|
Overall Study
COMPLETED
|
363
|
345
|
|
Overall Study
NOT COMPLETED
|
4
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Extubation Techniques in Critically Ill Adult Patients
Baseline characteristics by cohort
| Measure |
Positive Pressure Extubation Technique
n=367 Participants
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.
|
Traditional Extubation Technique
n=358 Participants
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.
|
Total
n=725 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
164 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
63 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
367 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
725 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
367 participants
n=5 Participants
|
358 participants
n=7 Participants
|
725 participants
n=5 Participants
|
|
High Risk of Extubation Failure
|
302 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
597 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within15 minutes after extubation.Clinical evidence of at least one of the following: * Upper airway obstruction * Desaturation * Vomiting
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants With Major Post Extubation Complications
|
89 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants With Minor Post Extubation Complications
|
144 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants With Overall Post Extubation Complications
|
190 Participants
|
197 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants With Post Extubation Pneumonia
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Within 72 hours after extubation.Use of Non Invasive Ventilation to treat the failure or need of reintubation.
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants With Extubation Failure
|
48 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Within 72 hours after extubation.Need of reintubation.
Outcome measures
| Measure |
Positive Pressure Extubation Technique
n=363 Participants
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.
|
Traditional Extubation Technique
n=345 Participants
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.
|
|---|---|---|
|
Number of Participants That Required Reintubation
|
44 Participants
|
51 Participants
|
Adverse Events
Positive Pressure Extubation Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 41 deaths
Traditional Extubation Technique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 45 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place