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

History of Changes

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

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):

Jones PM, Loh FL, Youssef HN, Turkstra TP. A randomized comparison of the GlideRite(®) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope(®). Can J Anaesth. 2011 Mar;58(3):256-61. Epub 2010 Dec 17.

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 June 13, 2013

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