A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.

June 25, 2014 updated by: John Viet Nguyen, Maisonneuve-Rosemont Hospital

A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.

The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria.

Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group.

The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia.

The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator.

Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera.

Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone.

Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure.

The data is then taken from the video and analyzed by a blinded operator.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Issam Tanoubi, MD
  • Phone Number: 4558 514-252-3400

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hopital Maisonneuve-Rosemont
        • Contact:
          • Issam Tanoubi, MD
          • Phone Number: 4558 514-252-3400
        • Contact:
        • Principal Investigator:
          • John Viet Nguyen, MD
        • Principal Investigator:
          • Issam Tanoubi, MD
        • Sub-Investigator:
          • Nadia Godin, Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA status 1-2
  • BMI < 35
  • Elective surgery
  • General Anesthesia

Exclusion Criteria:

  • Difficult intubation
  • Indication for rapid sequence intubation
  • Contraindication for cervical collar

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GRS (GlideRite®)
GlideScope® intubation with GRS® stylet of a simulated difficult airway
Device: GlideScope® intubation with GRS® stylet
GlideScope® intubation with GRS® stylet of a simulated difficult airway
Active Comparator: FIS (Flex-it® )
GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
Device: GlideScope® intubation with Flex-it® stylet
GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: During intubation
Time from start of laryngoscopy to confirmation of EtCO2
During intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sore throat/Hoarseness
Time Frame: Day 0 (immediate post-operative)
Scale of 0 to 3
Day 0 (immediate post-operative)
Sore throat/Hoarseness
Time Frame: Day 1 (24hr post-operative)
Scale of 0 to 3
Day 1 (24hr post-operative)
Verbal Intubation difficulty scale
Time Frame: 15 minutes after intubation
Scale of 1 to 10
15 minutes after intubation
Tube manipulation time
Time Frame: During Intubation
Time from start of tube manipulation to confirmation of EtCO2
During Intubation
Resistance during stylet extraction
Time Frame: 15 minutes after intubation
Scale of 1 to 5
15 minutes after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

  • Principal Investigator: John Viet Nguyen, MD, HMR
  • Study Director: Issam Tanoubi, MD, HMR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cér 14013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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