Study Summary
This trial will compare the feasibility of using the TCI Articulating Device to the GlideRite Rigid Stylet for tracheal intubation in difficult airway cases where intubation is predicted to be difficult.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: completed immediately after subject intubation
Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place
Need to use a maneuver called "corkscrew" ETT to pass glottis
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
Blood in airway
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
Time to intubate using either control or intervention
completed immediately after subject intubation
Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider
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
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
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Video Laryngoscope and TCI Articulating Introducer
1 of 1
Experimental Treatment
160 Total Participants · 1 Treatment Group
Primary Treatment: video-laryngoscope and TCI Articulating Introducer Device · No Placebo Group · N/A
Video Laryngoscope and TCI Articulating Introducer
Device
Experimental Group · 1 Intervention: video-laryngoscope and TCI Articulating Introducer Device · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completed immediately after subject intubation
Who is running the clinical trial?
University of UtahOTHER
1,001 Previous Clinical Trials
1,782,148 Total Patients Enrolled
University of LouisvilleLead Sponsor
314 Previous Clinical Trials
72,780 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Caplan, Robert A., Karen L. Posner, Richard J. Ward, and Frederick W. Cheney. 1990. “Adverse Respiratory Events in Anesthesia: A Closed Claims Analysis”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000542-199005000-00010.
- Lenhardt, Rainer, Mary Tyler Burkhart, Guy N. Brock, Sunitha Kanchi-Kandadai, Rachana Sharma, and Ozan Akça. 2014. “Is Video Laryngoscope-assisted Flexible Tracheoscope Intubation Feasible for Patients with Predicted Difficult Airway? A Prospective, Randomized Clinical Trial”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000000220.
- Sakles, John C., Stephen Chiu, Jarrod Mosier, Corrine Walker, and Uwe Stolz. 2013. “The Importance of First Pass Success When Performing Orotracheal Intubation in the Emergency Department”. Edited by Robert F. Reardon. Academic Emergency Medicine. Wiley. doi:10.1111/acem.12055.
- Mort, Thomas C.. 2004. “The Incidence and Risk Factors for Cardiac Arrest During Emergency Tracheal Intubation: A Justification for Incorporating the ASA Guidelines in the Remote Location”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2004.01.007.
- Lenhardt, Rainer, Mary Tyler Burkhart, Guy N. Brock, Sunitha Kanchi-Kandadai, Rachana Sharma, and Ozan Akça. 2014. “Is Video Laryngoscope-assisted Flexible Tracheoscope Intubation Feasible for Patients with Predicted Difficult Airway? A Prospective, Randomized Clinical Trial”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000000220.
- Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth. 2004 Nov;16(7):508-16. doi: 10.1016/j.jclinane.2004.01.007.
- Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220. Erratum In: Anesth Analg. 2015 Feb;120(2):495.
- Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.
- Rainer Lenhardt 2022. "Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04866472.
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