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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

757 participants

Primary outcome timeframe

5 minutes

Results posted on

2019-06-11

Participant Flow

Participant milestones

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

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 minutes

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.

Outcome measures

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 minutes

Population: 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

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 minutes

Time 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

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 minutes

defined 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

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 minutes

Population: 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

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

Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths

No Bougie (Endotracheal Tube First)

Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths

Serious adverse events

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

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

Audrey Hendrickson

HHRI

Phone: 6128737448

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place