Acute Respiratory Failure
Conditions
Brief summary
This prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.
Detailed description
The primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway). We will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic. We plan to enroll 374 patients with a difficult airway characteristic (DAC). The total enrollment for the trial will be higher, depending on the proportion of patients that have a DAC. Based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a DAC. To help achieve balanced randomization for patients with a DAC, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.
Interventions
DEVICEBougie
DEVICEEndotracheal tube
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy) 2. The patient must be presumed to be 18 years of age or older at the time of enrollment.
Exclusion criteria
1. Known anatomic distortion of the upper airway or perilaryngeal structures. 2. Prisoner or under arrest 3. Known or suspected to be pregnant, based on the opinion of the treating physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With First Pass Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Pass Success Without Hypoxemia | 5 minutes | 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. |
| Time to Intubation (First Attempt) | 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. |
| Esophageal Intubation | 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. |
| Hypoxemia | 5 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bougie On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
Bougie | 381 |
| 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 | 376 |
| Total | 757 |
Baseline characteristics
| Characteristic | Bougie | No Bougie (Endotracheal Tube First) | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 18 | 46 years STANDARD_DEVIATION 18 | 46 years STANDARD_DEVIATION 18 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 109 Participants | 121 Participants | 230 Participants |
| Sex: Female, Male Male | 272 Participants | 255 Participants | 527 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 47 / 371 | 50 / 374 |
| serious Total, serious adverse events | 12 / 381 | 11 / 376 |
Outcome results
Primary
Number of Participants With First Pass Success
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.
Time frame: 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bougie | Number of Participants With First Pass Success | 373 Participants |
| No Bougie (Endotracheal Tube First) | Number of Participants With First Pass Success | 328 Participants |
Secondary
Esophageal Intubation
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.
Time frame: 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bougie | Esophageal Intubation | 0 Participants |
| No Bougie (Endotracheal Tube First) | Esophageal Intubation | 3 Participants |
Secondary
First Pass Success Without Hypoxemia
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.
Time frame: 5 minutes
Population: The patients not included in this number had no oximetry waveform available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bougie | First Pass Success Without Hypoxemia | 317 Participants |
| No Bougie (Endotracheal Tube First) | First Pass Success Without Hypoxemia | 282 Participants |
Secondary
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.
Time frame: 5 minutes
Population: The patients not included in these numbers did not have a valid oximetry waveform during intubation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bougie | Hypoxemia | 47 Participants |
| No Bougie (Endotracheal Tube First) | Hypoxemia | 50 Participants |
Secondary
Time to Intubation (First Attempt)
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.
Time frame: 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bougie | Time to Intubation (First Attempt) | 38 seconds |
| No Bougie (Endotracheal Tube First) | Time to Intubation (First Attempt) | 36 seconds |