Oral Intubation
Conditions
Keywords
airway management, trauma, intubation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEtype of laryngoscope
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Sponsors
University of Maryland, Baltimore
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
* require emergency intubation
Exclusion criteria
* age \< 18 * require surgical airway on initial assessment * have known or strongly suspected spinal cord injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Survived to Hospital Discharge | 2 weeks, on average | Assessment of whether or not the patient was discharged alive from the study center |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Time to Perform the Intubation Procedure | Up to 100 seconds | How long (seconds) it takes the provider to perform the intubation procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 320 |
| 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 | 303 |
| Total | 623 |
Baseline characteristics
| Characteristic | Direct Laryngoscope | Video Laryngoscope | Total |
|---|---|---|---|
| Age, Continuous | 43 years | 42 years | 43 years |
| Region of Enrollment United States | 320 Participants | 303 Participants | 623 Participants |
| Sex: Female, Male Female | 76 Participants | 87 Participants | 163 Participants |
| Sex: Female, Male Male | 244 Participants | 216 Participants | 460 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 320 | 0 / 303 |
| serious Total, serious adverse events | 0 / 320 | 0 / 303 |
Outcome results
Primary
Number of Participants Who Survived to Hospital Discharge
Assessment of whether or not the patient was discharged alive from the study center
Time frame: 2 weeks, on average
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Laryngoscope | Number of Participants Who Survived to Hospital Discharge | 296 Participants |
| Video Laryngoscope | Number of Participants Who Survived to Hospital Discharge | 275 Participants |
Secondary
Length of Time to Perform the Intubation Procedure
How long (seconds) it takes the provider to perform the intubation procedure.
Time frame: Up to 100 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Laryngoscope | Length of Time to Perform the Intubation Procedure | 40 seconds |
| Video Laryngoscope | Length of Time to Perform the Intubation Procedure | 56 seconds |