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| Name | Class |
|---|---|
| University of Utah | OTHER |
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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.
Multi-Centered, Prospective, Randomized, Control Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscope and GlideRite Ridgid Stylet | Other |
| |
| Video Laryngoscope and TCI Articulating Introducer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 measured in seconds with an estimated time of 30 to 120 seconds from the start of intubation to endotracheal tube placement verified by CO2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | completed immediately after subject intubation |
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Inclusion Criteria:
Patients requiring oral endotracheal intubation
Age 18 years or older
Group A Criteria (need only one of the following criteria)
Group B Criteria (need three or more of the following)
Exclusion Criteria:
Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reiner Lenhardt, MD | Contact | 502-852-3122 | Rainer.lenhardt@louisville.edu | |
| Emily Drennan, MD | Contact | 801-581-6393 | emily.drennan@hsc.utah.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville School of Medicine | Recruiting | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15590254 | Background | 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. | |
| 23574475 | Background | Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055. |
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Subjects will be given an identification code (study number) that will be transcribed on all subject files. A master list containing the assigned identification code and the subjects name and medical record number will be kept separately by the research coordinator. All data will be de-identified
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Randomization to Control: Video-Laryngoscope and GlideRite Rigid Stylet vs Intervention: Video-Laryngoscope with TCI Articulating Device
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| 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. |
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| 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 |
| Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place |
| Blood in airway | Provider reports blood in airway after the end of the intubation | 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 |
| 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 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 |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| 2339799 | Background | 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. |
| 24842175 | Background | 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. |