Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

April 20, 2009 updated by: Lawson Health Research Institute
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • London Health Sciences Centre

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient who is ≥ 18 yrs. coming for elective surgery.
  • Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
  • Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

  • Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  • Any patient with cervical spine abnormalities.
  • Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
  • Any patient requiring rapid sequence induction.

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: Conventional Glidescope
Device: Conventional (reusable) Glidescope
Experimental: Single-use Glidescope
Device: Single-use Glidescope videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to intubation (seconds)
Time Frame: Immediate
Immediate

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of intubation
Time Frame: after intubation
after intubation
Number of intubation attempts per group
Time Frame: after intubation
after intubation
Incidence of trauma in each group
Time Frame: after intubation
after intubation
Number of failures to intubate per group
Time Frame: after intubation
after intubation
Use of external laryngeal pressure per group
Time Frame: after intubation
after intubation
Laryngoscopic grade distribution in each group
Time Frame: after intubation
after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Philip M Jones, MD, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

April 12, 2007

First Submitted That Met QC Criteria

April 12, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2009

Last Update Submitted That Met QC Criteria

April 20, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-07-040
  • 13025

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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