Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00884754
First received: April 20, 2009
Last updated: December 13, 2010
Last verified: December 2010
  Purpose

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.


Condition Intervention
Airway
Device: GlideScope rigid stylet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Time to Intubation (Seconds) [ Time Frame: 30-150 seconds (anticipated) ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rigid GlideScope Specific Stylet Device: GlideScope rigid stylet
Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.
Active Comparator: 90º curvature, malleable stylet Device: GlideScope rigid stylet
Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any adult patient scheduled for elective surgery.
  • ETT 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.
  • Patient with known 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: NCT00884754

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Philip M Jones, MD, FRCPC LHSC
  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, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00884754     History of Changes
Other Study ID Numbers: R-08-594, 15520
Study First Received: April 20, 2009
Results First Received: December 13, 2010
Last Updated: December 13, 2010
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 31, 2014