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

NCT ID: NCT02177240

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-09-30

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.

Conditions

Difficult Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GRS (GlideRite®)

GlideScope® intubation with GRS® stylet of a simulated difficult airway

Group Type: ACTIVE_COMPARATOR

GlideScope® intubation with GRS® stylet

Intervention Type: DEVICE

GlideScope® intubation with GRS® stylet of a simulated difficult airway

FIS (Flex-it® )

GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

Group Type: ACTIVE_COMPARATOR

GlideScope® intubation with Flex-it® stylet

Intervention Type: DEVICE

GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

Interventions

GlideScope® intubation with Flex-it® stylet

GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

Intervention Type: DEVICE

GlideScope® intubation with GRS® stylet

GlideScope® intubation with GRS® stylet of a simulated difficult airway

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Viet Nguyen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Viet Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

HMR

Issam Tanoubi, MD

Role: STUDY_DIRECTOR

HMR

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

John Viet Nguyen, MD

Role: CONTACT

john.viet.nguyen@umontreal.ca

514-252-3400 ext. 4558

Issam Tanoubi, MD

Role: CONTACT

514-252-3400 ext. 4558

Facility Contacts

John Nguyen, MD

Role: primary

john.viet.nguyen@umontreal.ca

514-252-3400 ext. 4558

Issam Tanoubi, MD

Role: backup

514-252-3400 ext. 4558

Other Identifiers

Cér 14013

Identifier Type: -

Identifier Source: org_study_id