NCT02177240

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Difficult Intubation

Interventions

Type	Name	Description
DEVICE	GlideScope® intubation with Flex-it® stylet	GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
DEVICE	GlideScope® intubation with GRS® stylet	GlideScope® intubation with GRS® stylet of a simulated difficult airway

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-06-27
• Last updated: 2014-06-27

Locations

1 site across 1 country: Canada