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The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.
On admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. This procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. We will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. The newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. Since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| direct laryngoscope | Active Comparator | emergency intubation with direct laryngoscopy technique |
|
| video laryngoscope | Active Comparator | emergency intubation with video laryngoscopy technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| type of laryngoscope | Device | Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Survived to Hospital Discharge | Assessment of whether or not the patient was discharged alive from the study center | 2 weeks, on average |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Time to Perform the Intubation Procedure | How long (seconds) it takes the provider to perform the intubation procedure. | Up to 100 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Yeatts, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Laryngoscope | emergency intubation with direct laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
| FG001 | Video Laryngoscope | emergency intubation with video laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Laryngoscope | emergency intubation with direct laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
| BG001 | Video Laryngoscope |
| 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 Who Survived to Hospital Discharge | Assessment of whether or not the patient was discharged alive from the study center | Posted | Count of Participants | Participants | 2 weeks, on average |
|
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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 | Direct Laryngoscope | emergency intubation with direct laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dale Yeatts, Principal Investigator | R Adams Cowley Shock Trauma Center | 443-909-0648 | djyeatts@gmail.com |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
emergency intubation with video laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Length of Time to Perform the Intubation Procedure | How long (seconds) it takes the provider to perform the intubation procedure. | Posted | Median | Inter-Quartile Range | seconds | Up to 100 seconds |
|
|
|
| 0 |
| 320 |
| 0 |
| 320 |
| EG001 | Video Laryngoscope | emergency intubation with video laryngoscopy technique type of laryngoscope: Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope | 0 | 303 | 0 | 303 |
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