Status:
RECRUITING
Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
University of Utah
Conditions:
Predicted Difficult Airway
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Multi-Centered, Prospective, Randomized, Control Trial
Eligibility Criteria
Inclusion
- Patients requiring oral endotracheal intubation
- Age 18 years or older
- Group A Criteria (need only one of the following criteria)
- History of difficult intubation
- History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery
- Group B Criteria (need three or more of the following)
- 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)
- 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
- Oropharyngeal view: modified Mallampati scale of 3 or 4
- Mouth opening \< 4 cm
- Protruding upper teeth (severe overbite)
- History of radiation to the neck
- 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)
- Body Mass Index (BMI) \>35 kg/m2
- Neck circumference .\> 40 cm in females and 43 cm in males measured at the thyroid cartilage
- Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above
Exclusion
- Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04866472
Start Date
April 26 2022
End Date
April 1 2027
Last Update
February 20 2025
Active Locations (2)
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1
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
2
University of Louisville
Louisville, Kentucky, United States, 40202