Difficult Intubation Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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