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Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation | Clinical Trials | Clareo Health

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

Comparison of Video Laryngoscope (VLS) With GlideRite Ridge Stylet vs Video Laryngoscope With the TCI Articulating Indroducer for Endotracheal Intubation in Predicted Difficult Airways. A Prospective Randomized Control Trial

NCT04866472•University of Louisville

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Multi-Centered, Prospective, Randomized, Control Trial

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients requiring oral endotracheal intubation
•Age 18 years or older
•Group A Criteria (need only one of the following criteria)
•1. History of difficult intubation
•2. History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery
•Group B Criteria (need three or more of the following)
•1. Thyromental distance \<6 cm (Defined as distance measured from the thyroid notch to the tip of the jaw with the head extended and the mouth closed)
•2. Sternomental distance \< 12 cm (Defined as distance measured as the straight line between the upper border of the manubrium sterni and the bony point of the mentum with the head in full extension and the mouth closed
•3. Oropharyngeal view: modified Mallampati scale of 3 or 4
•4. Mouth opening \< 4 cm
+6 more criteria

Exclusion Criteria

•Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing

Locations (2)

University of Louisville School of Medicine

Louisville, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Key Dates

Start Date

April 26, 2022

Primary Completion Date

August 1, 2026

Completion Date

April 1, 2027

Last Updated

February 20, 2025

Enrollment

160

ESTIMATED participants

Conditions

Predicted Difficult Airway

Interventions

video-laryngoscope and GlideRite Rigid Stylet

DEVICE

video-laryngoscope and TCI Articulating Introducer Device

DEVICE

Contacts

Reiner Lenhardt, MD

CONTACT

502-852-3122 Rainer.lenhardt@louisville.edu

Emily Drennan, MD

CONTACT

801-581-6393 emily.drennan@hsc.utah.edu