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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00884754
First Posted: April 21, 2009
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lawson Health Research Institute
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: REB )
First Submitted: April 20, 2009
First Posted: April 21, 2009
Results First Submitted: December 13, 2010
Results First Posted: January 11, 2011
Last Update Posted: January 11, 2011
Last Verified: December 2010