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

This study is not yet open for participant recruitment.
Verified September 2016 by Timothy Turkstra, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489605
First Posted: December 9, 2011
Last Update Posted: September 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Timothy Turkstra, Lawson Health Research Institute
December 8, 2011
December 9, 2011
September 8, 2016
July 2017
June 2018   (Final data collection date for primary outcome measure)
Duration of Intubation [ Time Frame: Day 1 ]
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 ]
    Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)
  • Incidence of trauma [ Time Frame: Day 1 ]
    Incidence of trauma
  • Number of failures to intubate [ Time Frame: Day 1 ]
    Number of failures to intubate
  • Use of external laryngeal pressure [ Time Frame: Day 1 ]
    Use of external laryngeal pressure
  • Laryngoscopic grade distribution [ Time Frame: Day 1 ]
    Laryngoscopic grade distribution according to Cormack and Lehane classification
  • Sore Throat [ Time Frame: Day 3 ]
    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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 2018
June 2018   (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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact: Timothy P Turkstra, MD, M. Eng 519 685-8500 ext 35677
Canada
 
 
NCT01489605
18477
No
Not Provided
Not Provided
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
September 2016

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