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

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.

Study Overview

• Status: Completed
• Conditions: Airway
• Intervention / Treatment: Device: GlideScope rigid stylet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Intubation (Seconds)	30-150 seconds (anticipated)

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Philip M Jones, MD, FRCPC, LHSC

Publications and helpful links

General Publications

• Jones PM, Loh FL, Youssef HN, Turkstra TP. A randomized comparison of the GlideRite((R)) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope((R)). Can J Anaesth. 2011 Mar;58(3):256-61. doi: 10.1007/s12630-010-9440-z. Epub 2010 Dec 17.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: April 20, 2009
• First Submitted That Met QC Criteria: April 20, 2009
• First Posted (ESTIMATE): April 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2011
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: R-08-594; 15520 (OTHER: REB)