GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study

February 26, 2019 updated by: Timothy Turkstra, Lawson Health Research Institute

Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

See above. The primary outcome is time to intubation.

Study Type

Interventional

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 Center University Hospital
      • London, Ontario, Canada, N6A5a5
        • London Health Sciences Centre Victoria Campus

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any adult patient booked for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

  1. Any patient with cervical spine abnormalities.
  2. Any patients with known or probable difficult airways.
  3. 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GlideScope Groove
Patients will be intubated using the GlideScope Groove device. (Verathon)
Device: GlideScope Groove
Patients will be intubated using the GlideScope Groove device. (Verathon)
Other Names:
  • Verathon
Active Comparator: Control: Standard GlideScope
Control: Patients will be intubated using standard practice, a standard GlideScope (Verathon)
Device: Control: Standard GlideScope
Patients will be intubated using the standard GlideScope. (Verathon)
Other Names:
  • Varathon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Intubation
Time Frame: Day 1
Duration of Intubation - Mask removal to ETCO2 confirmation
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of intubation
Time Frame: Day 1
Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)
Day 1
Incidence of trauma
Time Frame: Day 1
Incidence of trauma
Day 1
Number of failures to intubate
Time Frame: Day 1
Number of failures to intubate
Day 1
Use of external laryngeal pressure
Time Frame: Day 1
Use of external laryngeal pressure
Day 1
Laryngoscopic grade distribution
Time Frame: Day 1
Laryngoscopic grade distribution according to Cormack and Lehane classification
Day 1
Sore Throat
Time Frame: Day 3
Patients will be surveyed with respect to the incidence of post-operative sore throat.
Day 3

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Collaborators

University of Western Ontario, Canada

Investigators

  • Principal Investigator: Timothy Turkstra, MD, M. Eng, UWO

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 (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18477

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Intubation, Orotracheal

Clinical Trials on GlideScope Groove

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe