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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRS (GlideRite®) | Active Comparator | GlideScope® intubation with GRS® stylet of a simulated difficult airway |
|
| FIS (Flex-it® ) | Active Comparator | GlideScope® intubation with Flex-it® stylet of a simulated difficult airway |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlideScope® intubation with Flex-it® stylet | Device | GlideScope® intubation with Flex-it® stylet of a simulated difficult airway |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation time | Time from start of laryngoscopy to confirmation of EtCO2 | During intubation |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Viet Nguyen, MD | Contact | 514-252-3400 | 4558 | john.viet.nguyen@umontreal.ca |
| Issam Tanoubi, MD | Contact | 514-252-3400 | 4558 |
| Name | Affiliation | Role |
|---|---|---|
| John Viet Nguyen, MD | HMR | Principal Investigator |
| Issam Tanoubi, MD | HMR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Maisonneuve-Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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| GlideScope® intubation with GRS® stylet | Device | GlideScope® intubation with GRS® stylet of a simulated difficult airway |
|
| 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 |