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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bougie | Active Comparator | On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube. |
|
| No bougie (endotracheal tube first) | Active Comparator | On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bougie | Device |
| ||
| Endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt. | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29800096 | Derived | Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bougie | On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube. Bougie |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bougie | On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube. Bougie |
| BG001 | No Bougie (Endotracheal Tube First) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt. | Posted | Count of Participants | Participants | 5 minutes |
|
5 minutes following intubation
We did not monitor all-cause mortality during the hospital stay, as this trial examined ED intubation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bougie | On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube. Bougie |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest in the ED at any time | Cardiac disorders | Non-systematic Assessment | All were unrelated to study participation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Oxygen saturation less than 90 % during or within 1 minute of intubation completion. This outcome only includes participants on whom we were able to record an oxygen saturation during intubation. Therefore, it is less than the total. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Audrey Hendrickson | HHRI | 6128737448 | audrey.hendrickson@hcmed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2016 | Apr 26, 2019 | Prot_SAP_000.pdf |
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|
| 5 minutes |
| 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. | 5 minutes |
| 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. | 5 minutes |
| 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. | 5 minutes |
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
Endotracheal tube
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | The patients not included in this number had no oximetry waveform available | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | seconds | 5 minutes |
|
|
|
| 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. | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| 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. | The patients not included in these numbers did not have a valid oximetry waveform during intubation. | Posted | Count of Participants | Participants | 5 minutes |
|
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| 0 |
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| 12 |
| 381 |
| 47 |
| 371 |
| EG001 | 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 | 0 | 0 | 11 | 376 | 50 | 374 |
|
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