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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: GlideScope® intubation with Flex-it® stylet
* Device: GlideScope® intubation with GRS® stylet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GRS (GlideRite®)<br>GlideScope® intubation with GRS® stylet of a simulated difficult airway | Device: GlideScope® intubation with GRS® stylet<br>* GlideScope® intubation with GRS® stylet of a simulated difficult airway<br>|
| Active Comparator: FIS (Flex-it® )<br>GlideScope® intubation with Flex-it® stylet of a simulated difficult airway | Device: GlideScope® intubation with Flex-it® stylet<br>* GlideScope® intubation with Flex-it® stylet of a simulated difficult airway<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time from start of laryngoscopy to confirmation of EtCO2 | During intubation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flex-it®, GlideScope®, GlideRite®, Difficult intubation