Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
January 11, 2011
CompletedJanuary 11, 2011
December 1, 2010
8 months
April 20, 2009
December 13, 2010
December 13, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Intubation (Seconds)
30-150 seconds (anticipated)
Study Arms (2)
rigid GlideScope Specific Stylet
EXPERIMENTAL90º curvature, malleable stylet
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Related Publications (1)
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.
PMID: 21165728DERIVED
Results Point of Contact
- Title
- Philip Jones
- Organization
- London Health Sciences Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Philip M Jones, MD, FRCPC
LHSC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 21, 2009
Study Start
March 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
January 11, 2011
Results First Posted
January 11, 2011
Record last verified: 2010-12