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NCT04866472NARecruiting

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

University of Louisville

Start Date

4/26/2022

Completion Date

4/1/2027

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 Criteria

Age Range: 18 years to No maximum

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 5. Protruding upper teeth (severe overbite) 6. History of radiation to the neck 7. Limited neck movement: inability to extend and flex neck \>90° from full extension to full flexion or presence of cervical spine pathologies and fractures (e.g., C-collar in place) 8. Body Mass Index (BMI) \>35 kg/m2 9. Neck circumference .\> 40 cm in females and 43 cm in males measured at the thyroid cartilage 10. Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above Exclusion Criteria: Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing

Interventions

DEVICE

video-laryngoscope and GlideRite Rigid Stylet

DEVICE

video-laryngoscope and TCI Articulating Introducer Device

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Conditions

Predicted Difficult Airway

Locations

University of Louisville School of Medicine

Louisville, Kentucky 40202

United States

University of Louisville

Louisville, Kentucky 40202

United States