- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01235065
GlideScope Versus Direct Laryngoscope for Emergency Intubation
May 4, 2023 updated by: University of Maryland, Baltimore
GlideScope vs. Direct Laryngoscope for Emergency Intubation
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
623
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- R Adams Cowley Shock Trauma Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- require emergency intubation
Exclusion Criteria:
- age < 18
- require surgical airway on initial assessment
- have known or strongly suspected spinal cord injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: direct laryngoscope
emergency intubation with direct laryngoscopy technique
|
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Other Names:
|
|
Active Comparator: video laryngoscope
emergency intubation with video laryngoscopy technique
|
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Survived to Hospital Discharge
Time Frame: 2 weeks, on average
|
Assessment of whether or not the patient was discharged alive from the study center
|
2 weeks, on average
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Time to Perform the Intubation Procedure
Time Frame: Up to 100 seconds
|
How long (seconds) it takes the provider to perform the intubation procedure.
|
Up to 100 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dale Yeatts, MD, University of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
November 16, 2016
Study Completion (Actual)
November 16, 2016
Study Registration Dates
First Submitted
October 22, 2010
First Submitted That Met QC Criteria
November 3, 2010
First Posted (Estimated)
November 5, 2010
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00042451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
None exists
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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