NCT04866472 Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation
| NCT ID | NCT04866472 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Predicted Difficult Airway |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-04-26 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-04-26 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 device is equivalent to using the GlideRite Rigid Stylet with video-laryngoscope.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04866472 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Predicted Difficult Airway. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04866472 currently recruiting?
Yes, NCT04866472 is actively recruiting participants. Contact the research team at Rainer.lenhardt@louisville.edu for enrollment information.
Where is the NCT04866472 trial being conducted?
This trial is being conducted at Louisville, United States, Louisville, United States.
Who is sponsoring the NCT04866472 clinical trial?
NCT04866472 is sponsored by University of Louisville. The trial plans to enroll 160 participants.