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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

December 8, 2011
January 12, 2013
July 2013
June 2014   (final data collection date for primary outcome measure)
Duration of Intubation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Duration of Intubation - Mask removal to ETCO2 confirmation
Same as current
Complete list of historical versions of study NCT01489605 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study
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.

See above. The primary outcome is time to intubation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intubation, Orotracheal
  • Device: GlideScope Groove
    Patients will be intubated using the GlideScope Groove device. (Verathon)
    Other Name: Verathon
  • Device: Control: Standard GlideScope
    Patients will be intubated using the standard GlideScope. (Verathon)
    Other Name: Varathon
  • Experimental: GlideScope Groove
    Patients will be intubated using the GlideScope Groove device. (Verathon)
    Intervention: Device: GlideScope Groove
  • Active Comparator: Control: Standard GlideScope
    Control: Patients will be intubated using standard practice, a standard GlideScope (Verathon)
    Intervention: Device: Control: Standard GlideScope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
130
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact: Timothy P Turkstra, MD, M. Eng 519 685-8500 ext 35677
Canada
 
NCT01489605
18477
No
Timothy Turkstra, Lawson Health Research Institute
Lawson Health Research Institute
University of Western Ontario, Canada
Principal Investigator: Timothy Turkstra, MD, M. Eng UWO
Lawson Health Research Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP