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.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Intubation time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Intubation time
Time Frame: During intubation
Time from start of laryngoscopy to confirmation of EtCO2
Secondary Outcomes
- Sore throat/Hoarseness(Day 1 (24hr post-operative))
- Verbal Intubation difficulty scale(15 minutes after intubation)
- Tube manipulation time(During Intubation)
- Resistance during stylet extraction(15 minutes after intubation)
Investigators
John Viet Nguyen
MD
Maisonneuve-Rosemont Hospital