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

Maisonneuve-Rosemont Hospital

Status: Unknown

Conditions: Difficult Intubation

Treatments: Device: GlideScope® intubation with GRS® stylet; Device: GlideScope® intubation with Flex-it® stylet

Study type: Interventional

Funder types: Other

Identifiers

NCT02177240

Cér 14013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups

GRS (GlideRite®)

Active Comparator group

Description:

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

Treatment:

Device: GlideScope® intubation with GRS® stylet

FIS (Flex-it® )

Active Comparator group

Description:

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

Treatment:

Device: GlideScope® intubation with Flex-it® stylet