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
Conditions
Predicted Difficult Airway
Locations
University of Louisville School of Medicine
Louisville, Kentucky 40202
United States
University of Louisville
Louisville, Kentucky 40202
United States