Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • video-laryngoscope and GlideRite Rigid Stylet

    Device

    Once 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

    Device

    In 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

160 Participants
are divided into 2 treatment groups
Group A: Video Laryngoscope and GlideRite Ridgid StyletOther 1 intervention
Group B: Video Laryngoscope and TCI Articulating IntroducerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
time measured in seconds with an estimated time of 30 to 120 seconds from the start of intubation to endotracheal tube placement verified by CO2

Secondary outcomes

1

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

Time frame
completed immediately after subject intubation
2

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

Time frame
Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place
3

Blood in airway

Provider reports blood in airway after the end of the intubation

Time frame
Period in seconds with an estimated time of 30 to 120 seconds between start of use of TCI Articulating Device to placement of ETT tube or failure to place
4

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

Time frame
Time measured in seconds, with an estimated time of 30 to 120 seconds, from time of first view of glottis to time ETT placement or failure to place

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Louisville

Lead sponsor

University of Utah

Collaborator