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

This study is not yet open for participant recruitment.
Verified January 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01489605
First received: December 8, 2011
Last updated: January 12, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Intubation, Orotracheal
 Device: GlideScope Groove
Device: Control: Standard GlideScope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study

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 ]
    Duration of Intubation - Mask removal to ETCO2 confirmation


Secondary Outcome Measures:
  • Ease of intubation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)

  • Incidence of trauma [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Incidence of trauma

  • Number of failures to intubate [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    Number of failures to intubate

  • Use of external laryngeal pressure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Use of external laryngeal pressure

  • Laryngoscopic grade distribution [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Laryngoscopic grade distribution according to Cormack and Lehane classification

  • Sore Throat [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Patients will be surveyed with respect to the incidence of post-operative sore throat.


Estimated Enrollment: 130
Study Start Date: July 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Varathon

Detailed Description:

See above. The primary outcome is time to intubation.

  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.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489605

Contacts
Contact: Timothy P Turkstra, MD, M. Eng 519 685-8500 ext 35677

Locations
Canada, Ontario
London Health Sciences Center University Hospital Not yet recruiting
London, Ontario, Canada, N6A5A5
Contact: Timothy P Turkstra, MD, M. Eng     519 685-8500 ext 35677        
London Health Sciences Centre Victoria Campus Not yet recruiting
London, Ontario, Canada, N6A5a5
Contact: Timothy Turkstra, MD, M. Eng     519 685-8500 ext 35677        
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Timothy Turkstra, MD, M. Eng UWO
  More Information

No publications provided

Responsible Party: Timothy Turkstra, Staff Anesthesiologist and Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01489605     History of Changes
Other Study ID Numbers: 18477
Study First Received: December 8, 2011
Last Updated: January 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Orotracheal intubation, videolaryngoscopy

ClinicalTrials.gov processed this record on May 23, 2013