About this trial
This study will assess the feasibility of using the TCI Articulating Device with video-laryngoscope in predictive, difficult airway, endotracheal intubation cases. It is meant to show the use of this device is equivalent to using the GlideRite Rigid Stylet with video-laryngoscope.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients requiring oral endotracheal intubation
Age 18 years or older
Group A Criteria (need only one of the following criteria)
History of difficult intubation
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
video-laryngoscope and GlideRite Rigid Stylet
DeviceOnce subject is in the operating room, standard monitoring will be instituted including nerve stimulator. Induction will follow standard practice.Once full muscle relaxation is confirmed with a train of four of 0/4 laryngoscopy will be preformed using a video-laryngoscope (VLS) with a #3 blade for women and a #4 blade men. Endotracheal intubation will be performed using a #7 endotracheal tube in women and # 8 in men using the GlideRite Rigid Stylet. The stylet will be shaped to the curvature of the blade of the VLS and lubricated with a water-based lubricant. After successful tracheal intubation the circuit will be connected and ventilation confirmed with capnography and auscultation.
video-laryngoscope and TCI Articulating Introducer Device
DeviceIn the operating room, standard monitoring will be instituted including nerve simulator. Induction will follow standard practice. Once full muscle relaxation is achieved (train of four of 0/4) laryngoscopy will be performed using a video-laryngoscope (VLS) using a #3 blade in women and a #4 blade in men. A #7 endotracheal tube will be used for women and a #8 for men. Endotracheal intubation will be performed by placing the tube on the back of the TCI articulating introducer, after shaft is lubricated with a water based lubricant. The tip of the TCI articulating introducer will be maneuvered into the trachea and advanced until the green zone of the introducer shaft is adjacent to the glottis. The handle of the articulating introducer will then be removed and the ETT will be advanced over the articulating introducer and into the trachea via Seldinger's technique. Once in place the respiratory circuit will be connected and confirmed with capnography and auscultation.
Treatment groups
Trial outcomes
Primary outcomes
Time to successful intubation using a combination of video-laryngoscope and TCI Articulating Device will be equilivant to intubation success usinging a combination of video-laryngoscope and GlideRite Rigid Stylet
successful intubation
Secondary outcomes
Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider
completion by provider of "Ease of Intubation" visual score scale measured from 0 to 100, with 0 being impossible intubation and 100 perfectly easy intubation
Need to use a maneuver called "corkscrew" ETT to pass glottis
provider confirms use of "corkscrew" maneuver during or after intubation, scale as yes or no
Blood in airway
Provider reports blood in airway after the end of the intubation
Time to intubate using either control or intervention
Time from first view of glottis to ETT placement or failure to place, up to three attempts using each technique
Sponsors and contacts
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University of Louisville
Lead sponsor
University of Utah
Collaborator