- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488695
GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation
February 26, 2019 updated by: Timothy Turkstra, Lawson Health Research Institute
Comparison of GlideScope Groove to Macintosh Blade for Orotracheal Intubation With Double-Lumen Endotracheal Tube: a Randomised Controlled Trial
A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior surface of the blade to guide the endotracheal tube, which is advanced in the track as opposed to "free-hand" along the inferior surface, where the camera is located.
This new GlideScope can be used for double-lumen endotracheal tubes (DLT).
The investigators hypothesize that this GlideScope will be easier to use than the Macintosh blade.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
-
-
Ontario
-
London, Ontario, Canada, N6A5A5
- London Health Sciences Center University Hospital
-
London, Ontario, Canada, N6A5A5
- Victoria Hospital
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any adult patient booked for elective surgery requiring orotracheal intubation with a double lumen endotracheal tube.
Exclusion Criteria:
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways.
- 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: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GlideScope Groove
Patient will be intubated using the GlideScope Groove device.
|
GlideScope Groove
Other Names:
|
|
Active Comparator: Control
Control Group: Macintosh Blade
|
Control: Patients will be intubated using the Macintosh blade
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of Intubation
Time Frame: Day 1
|
The intubation will be timed using a stopwatch.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of failures to intubate
Time Frame: Day 1
|
Number of failures to intubate
|
Day 1
|
|
Number of intubation attempts
Time Frame: Day 1
|
Number of intubation attempts
|
Day 1
|
|
Use of external laryngeal pressure
Time Frame: Day 1
|
Whether or not external laryngeal pressure was needed to facilitate tracheal intubation
|
Day 1
|
|
Laryngoscopic grade distribution
Time Frame: Day 1
|
Cormack and Lehane Grade observed during laryngoscopy
|
Day 1
|
|
Presence of Sore throat
Time Frame: Day 3
|
Sore throat will be graded on POD #2 as none, mild, moderate, or severe
|
Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Timothy P Turkstra, University of Western Ontario, Canada
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 6, 2011
First Submitted That Met QC Criteria
December 7, 2011
First Posted (Estimate)
December 8, 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
- 18478
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.
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