GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01488695
First received: December 6, 2011
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Intubation, Intratracheal
Device: GlideScope Groove
Device: Control: Macintosh blade

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of GlideScope Groove to Macintosh Blade for Orotracheal Intubation With Double-Lumen Endotracheal Tube: a Randomised Controlled Trial

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Duration of Intubation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The intubation will be timed using a stopwatch.


Secondary Outcome Measures:
  • Number of intubation attempts [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of intubation attempts

  • Number of failures to intubate [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of failures to intubate

  • Use of external laryngeal pressure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Whether or not external laryngeal pressure was needed to facilitate tracheal intubation

  • Laryngoscopic grade distribution [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Cormack and Lehane Grade observed during laryngoscopy

  • Presence of Sore throat [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Sore throat will be graded on POD #2 as none, mild, moderate, or severe


Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GlideScope Groove
Patient will be intubated using the GlideScope Groove device.
Device: GlideScope Groove
GlideScope Groove
Other Name: Verathon
Active Comparator: Control
Control Group: Macintosh Blade
Device: Control: Macintosh blade
Control: Patients will be intubated using the Macintosh blade
Other Name: Mac 3, 4

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any adult patient booked for elective surgery requiring orotracheal intubation with a double lumen endotracheal tube.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488695

Contacts
Contact: Timothy Turkstra, MD 519685-8500 ext 35677

Locations
Canada, Ontario
London Health Sciences Center University Hospital
London, Ontario, Canada, N6A5A5
Victoria Hospital Not yet recruiting
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Timothy P Turkstra University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Timothy Turkstra, Staff anesthesiologist and Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01488695     History of Changes
Other Study ID Numbers: 18478
Study First Received: December 6, 2011
Last Updated: January 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
intubation
double lumen tube

ClinicalTrials.gov processed this record on September 18, 2014