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

Difficult Intubation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02177240
• Other study ID #: Cér 14013
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2014
• Last updated: June 25, 2014
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: June 2014
• Source: Maisonneuve-Rosemont Hospital
• Contact: John Viet Nguyen, MD
• Phone: 514-252-3400
• Email: john.viet.nguyen[@]umontreal.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• GlideScope® intubation with Flex-it® stylet
GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
• GlideScope® intubation with GRS® stylet
GlideScope® intubation with GRS® stylet of a simulated difficult airway

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	Time from start of laryngoscopy to confirmation of EtCO2	During intubation	No
Secondary	Sore throat/Hoarseness	Scale of 0 to 3	Day 0 (immediate post-operative)	Yes
Secondary	Sore throat/Hoarseness	Scale of 0 to 3	Day 1 (24hr post-operative)	Yes
Secondary	Verbal Intubation difficulty scale	Scale of 1 to 10	15 minutes after intubation	No
Secondary	Tube manipulation time	Time from start of tube manipulation to confirmation of EtCO2	During Intubation	No
Secondary	Resistance during stylet extraction	Scale of 1 to 5	15 minutes after intubation	No