Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00459797
First received: April 12, 2007
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.


Condition Intervention
Healthy
Device: Conventional (reusable) Glidescope
Device: Single-use Glidescope videolaryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Time to intubation (seconds) [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of intubation [ Time Frame: after intubation ] [ Designated as safety issue: No ]
  • Number of intubation attempts per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
  • Incidence of trauma in each group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
  • Number of failures to intubate per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
  • Use of external laryngeal pressure per group [ Time Frame: after intubation ] [ Designated as safety issue: No ]
  • Laryngoscopic grade distribution in each group [ Time Frame: after intubation ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Glidescope Device: Conventional (reusable) Glidescope
Experimental: Single-use Glidescope Device: Single-use Glidescope videolaryngoscope

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any patient who is ≥ 18 yrs. coming for elective surgery.
  • Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
  • Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

  • Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  • Any patient with cervical spine abnormalities.
  • Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
  • Any patient requiring rapid sequence induction.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00459797

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Philip M Jones, MD London Health Sciences Centre
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philip Jones, LHSC
ClinicalTrials.gov Identifier: NCT00459797     History of Changes
Other Study ID Numbers: R-07-040, 13025
Study First Received: April 12, 2007
Last Updated: April 20, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
GlideScope
cobalt
single-use
intubation
airway
Elective surgical patients requiring orotracheal intubation

ClinicalTrials.gov processed this record on October 19, 2014