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| Sponsors and Collaborators: |
Lawson Health Research Institute London Health Sciences Centre St. Joseph Hospital |
|---|---|
| Information provided by: | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00771628 |
Purpose
Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different ETT stylets. The primary outcome is time to intubation.
The null hypothesis is that there will be no difference.
The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a high-resolution camera embedded into a plastic laryngoscope blade. An LED provides illumination. The GlideScope often provides a good laryngoscopic view, but passing the endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60 degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that the ETT distal tip can be positioned anteriorly. Various authors have recommended different angles of the ETT to optimally place it into the trachea, including matching the GlideScope's 60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies demonstrated that 90 degree sharp bend was both faster and subjectively easier in a heterogeneous group of intubators. With the introduction of the Flex-It stylet by Parker Medical, the question arises as to the the best configuration of stylet for the ETT. Therefore, this prospective, randomized, single-blinded trial is proposed.
| Condition | Intervention |
|---|---|
|
Intubation |
Device: Flex-It Stylet Device: Standard malleable stylet |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment |
| Official Title: | Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Flex-It Stylet: Experimental
Patients will be intubated using the GlideScope with an ETT fitted with a Flex-It stylet.
|
Device: Flex-It Stylet
Patients will be intubated using the GlideScope with an ETT fitted with a Flex-It stylet.
|
| 2 Malleable: Active Comparator |
Device: Standard malleable stylet
Patients will be intubated using the GlideScope with an ETT fitted with a standard malleable stylet.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Timothy P Turkstra, MD | 519 685-8500 ext 35677 | |
| Contact: Philip M Jones, MD | 519 685-8500 ext 36306 |
| Canada, Ontario | |
| London Health Sciences Center | Recruiting |
| London, Ontario, Canada | |
| Contact: Timothy P Turkstra, MD 519 685-8500 ext 35677 | |
| Principal Investigator: | Timothy P Turkstra, MD | University of Western Ontario, Canada |
More Information
| Responsible Party: | University of Western Ontario ( Timothy Turkstra ) |
| Study ID Numbers: | R-08-111, 13949 |
| Study First Received: | October 10, 2008 |
| Last Updated: | October 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00771628 |
| Health Authority: | Canada: Ethics Review Committee |
|
Intubation, Flex-It, stylet, GlideScope |
