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GlideScope Versus Direct Laryngoscope for Emergency Intubation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dale Yeatts, University of Maryland
ClinicalTrials.gov Identifier:
NCT01235065
First received: October 22, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Oral Intubation
 Device: type of laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GlideScope vs. Direct Laryngoscope for Emergency Intubation

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Survival to hospital discharge [ Time Frame: 2 weeks, on average ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of time to perform the intubation procedure [ Time Frame: 30 seconds, on average ] [ Designated as safety issue: Yes ]

Enrollment: 658
Study Start Date: July 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: direct laryngoscope
emergency intubation with direct laryngoscope
 Device: type of laryngoscope
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Other Name: Macintosh direct laryngoscope vs. GlideScope video laryngoscope
Active Comparator: video laryngoscope
emergency intubation with video laryngoscope
 Device: type of laryngoscope
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
Other Name: Macintosh direct laryngoscope vs. GlideScope video laryngoscope

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • require emergency intubation

Exclusion Criteria:

  • age < 18
  • require surgical airway on initial assessment
  • have known or strongly suspected spinal cord injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235065

Locations
United States, Maryland
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Dale Yeatts, MD University of Maryland
  More Information

No publications provided

Responsible Party: Dale Yeatts, Assistant Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01235065     History of Changes
Other Study ID Numbers: HP-00042451
Study First Received: October 22, 2010
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
airway management
trauma
intubation

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013