GlideScope Versus Direct Laryngoscope for Emergency Intubation
Primary Purpose
Oral Intubation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
type of laryngoscope
Sponsored by

About this trial
This is an interventional treatment trial for Oral Intubation focused on measuring airway management, trauma, intubation
Eligibility Criteria
Inclusion Criteria:
- require emergency intubation
Exclusion Criteria:
- age < 18
- require surgical airway on initial assessment
- have known or strongly suspected spinal cord injury
Sites / Locations
- R Adams Cowley Shock Trauma Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
direct laryngoscope
video laryngoscope
Arm Description
emergency intubation with direct laryngoscopy technique
emergency intubation with video laryngoscopy technique
Outcomes
Primary Outcome Measures
Number of Participants Who Survived to Hospital Discharge
Assessment of whether or not the patient was discharged alive from the study center
Secondary Outcome Measures
Length of Time to Perform the Intubation Procedure
How long (seconds) it takes the provider to perform the intubation procedure.
Full Information
NCT ID
NCT01235065
First Posted
October 22, 2010
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01235065
Brief Title
GlideScope Versus Direct Laryngoscope for Emergency Intubation
Official Title
GlideScope vs. Direct Laryngoscope for Emergency Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 16, 2016 (Actual)
Study Completion Date
November 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Intubation
Keywords
airway management, trauma, intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
623 (Actual)
8. Arms, Groups, and Interventions
Arm Title
direct laryngoscope
Arm Type
Active Comparator
Arm Description
emergency intubation with direct laryngoscopy technique
Arm Title
video laryngoscope
Arm Type
Active Comparator
Arm Description
emergency intubation with video laryngoscopy technique
Intervention Type
Device
Intervention Name(s)
type of laryngoscope
Other Intervention Name(s)
Macintosh direct laryngoscope vs. GlideScope video laryngoscope
Intervention Description
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Primary Outcome Measure Information:
Title
Number of Participants Who Survived to Hospital Discharge
Description
Assessment of whether or not the patient was discharged alive from the study center
Time Frame
2 weeks, on average
Secondary Outcome Measure Information:
Title
Length of Time to Perform the Intubation Procedure
Description
How long (seconds) it takes the provider to perform the intubation procedure.
Time Frame
Up to 100 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
require emergency intubation
Exclusion Criteria:
age < 18
require surgical airway on initial assessment
have known or strongly suspected spinal cord injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Yeatts, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
R Adams Cowley Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
None exists
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GlideScope Versus Direct Laryngoscope for Emergency Intubation
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