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

Not Applicable

• Conditions: Difficult Intubation
• Interventions: Device: GlideScope® intubation with GRS® stylet; Device: GlideScope® intubation with Flex-it® stylet

• Registration Number: NCT02177240
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief 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.

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-29
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Study First Posted: 2014-06-27
• Last Update Posted: 2014-06-27
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GRS (GlideRite®)	GlideScope® intubation with GRS® stylet	GlideScope® intubation with GRS® stylet of a simulated difficult airway
FIS (Flex-it® )	GlideScope® intubation with Flex-it® stylet	GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

Primary Outcome Measures

Name	Time	Method
Intubation time	During intubation	Time from start of laryngoscopy to confirmation of EtCO2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada