Trial Outcomes & Findings for Bougie Use in Emergency Airway Management (NCT NCT02902146)
NCT ID: NCT02902146
Last Updated: 2019-06-11
Results Overview
First pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur: 1. the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie. 2. if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth. A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt.
COMPLETED
NA
757 participants
5 minutes
2019-06-11
Participant Flow
Participant milestones
| Measure |
Bougie
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Overall Study
STARTED
|
381
|
376
|
|
Overall Study
COMPLETED
|
381
|
376
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bougie
n=381 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=376 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
Total
n=757 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 18 • n=381 Participants
|
46 years
STANDARD_DEVIATION 18 • n=376 Participants
|
46 years
STANDARD_DEVIATION 18 • n=757 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=381 Participants
|
121 Participants
n=376 Participants
|
230 Participants
n=757 Participants
|
|
Sex: Female, Male
Male
|
272 Participants
n=381 Participants
|
255 Participants
n=376 Participants
|
527 Participants
n=757 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 5 minutesFirst pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur: 1. the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie. 2. if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth. A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt.
Outcome measures
| Measure |
Bougie
n=381 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=376 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Number of Participants With First Pass Success
|
373 Participants
|
328 Participants
|
SECONDARY outcome
Timeframe: 5 minutesPopulation: The patients not included in this number had no oximetry waveform available
First pass success without hypoxemia. Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff. A patient will be considered to achieve this outcome if 1) they are intubated successfully on the first attempt, and 2) do not experience hypoxemia on the first attempt.
Outcome measures
| Measure |
Bougie
n=371 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=366 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
First Pass Success Without Hypoxemia
|
317 Participants
|
282 Participants
|
SECONDARY outcome
Timeframe: 5 minutesTime to intubation will be defined as the time elapsed between the beginning of the intubation attempt to inflation of the ETT cuff when the tube is in the trachea.
Outcome measures
| Measure |
Bougie
n=381 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=376 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Time to Intubation (First Attempt)
|
38 seconds
Interval 29.0 to 51.0
|
36 seconds
Interval 25.0 to 54.0
|
SECONDARY outcome
Timeframe: 5 minutesdefined as passage of the ETT into the esophagus, with subsequent ventilation, and then removal. Clinically, esophageal intubation is identified by the absence of end-tidal carbon dioxide, abnormal physical exam, and hypoxia. This does not count passage of the ETT into the esophagus during the attempt if the ETT is removed during the attempt.
Outcome measures
| Measure |
Bougie
n=381 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=376 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Esophageal Intubation
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 minutesPopulation: The patients not included in these numbers did not have a valid oximetry waveform during intubation.
Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff.
Outcome measures
| Measure |
Bougie
n=371 Participants
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=364 Participants
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Hypoxemia
|
47 Participants
|
50 Participants
|
Adverse Events
Bougie
No Bougie (Endotracheal Tube First)
Serious adverse events
| Measure |
Bougie
n=371 participants at risk;n=381 participants at risk
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=374 participants at risk;n=376 participants at risk
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest in the ED at any time
|
3.1%
12/381 • 5 minutes following intubation
We did not monitor all-cause mortality during the hospital stay, as this trial examined ED intubation.
|
2.9%
11/376 • 5 minutes following intubation
We did not monitor all-cause mortality during the hospital stay, as this trial examined ED intubation.
|
Other adverse events
| Measure |
Bougie
n=371 participants at risk;n=381 participants at risk
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie
|
No Bougie (Endotracheal Tube First)
n=374 participants at risk;n=376 participants at risk
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
12.7%
47/371 • 5 minutes following intubation
We did not monitor all-cause mortality during the hospital stay, as this trial examined ED intubation.
|
13.4%
50/374 • 5 minutes following intubation
We did not monitor all-cause mortality during the hospital stay, as this trial examined ED intubation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place