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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01235065
Other study ID # HP-00042451
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2008
Est. completion date November 16, 2016

Study information

Verified date June 2018
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 623
Est. completion date November 16, 2016
Est. primary completion date November 16, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - require emergency intubation Exclusion Criteria: - age < 18 - require surgical airway on initial assessment - have known or strongly suspected spinal cord injury

Study Design


Related Conditions & MeSH terms


Intervention

Device:
type of laryngoscope
Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope

Locations

Country Name City State
United States R Adams Cowley Shock Trauma Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Survived to Hospital Discharge Assessment of whether or not the patient was discharged alive from the study center 2 weeks, on average
Secondary Length of Time to Perform the Intubation Procedure How long (seconds) it takes the provider to perform the intubation procedure. Up to 100 seconds
See also
  Status Clinical Trial Phase
Completed NCT01091948 - GlideScope Video Laryngoscope Versus Fiberoptic Intubation N/A