Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
London Health Sciences Centre
St. Joseph Hospital Health Center
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00771628
First received: October 10, 2008
Last updated: July 10, 2009
Last verified: July 2009
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Time to Intubation [ Time Frame: Prospective 10-150 seconds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of Intubation Visual Analog Scale [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flex-It Stylet
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.
Active Comparator: 2 Malleable 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
Criteria

Inclusion Criteria:

  1. * Any adult patient scheduled for elective surgery.
  2. ETT is indicated for the procedure in the opinion of the attending anesthesiologist.
  3. Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

  1. Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
  2. * Patient with known cervical spine abnormalities.
  3. * 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).
  4. Any patient requiring rapid sequence induction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771628

Locations
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
London Health Sciences Centre
St. Joseph Hospital Health Center
Investigators
Principal Investigator: Timothy P Turkstra, MD University of Western Ontario, Canada
  More Information

No publications provided by Lawson Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Turkstra, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00771628     History of Changes
Other Study ID Numbers: R-08-111, 13949
Study First Received: October 10, 2008
Last Updated: July 10, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Intubation, Flex-It, stylet, GlideScope

ClinicalTrials.gov processed this record on October 29, 2014