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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
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Intubation focused on measuring airway management, trauma, intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 22, 2010
Last Updated
May 4, 2023
Sponsor
University of Maryland, Baltimore
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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

Learn more about this trial

GlideScope Versus Direct Laryngoscope for Emergency Intubation

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