Comparing two devices for difficult airway intubation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the TCI Articulating Introducer Device in conjunction with a video-laryngoscope for patients predicted to have difficult airway intubation. It aims to determine if this device is as effective as the GlideRite Rigid Stylet when used with a video-laryngoscope. The study is a multi-centered, prospective, randomized, controlled trial involving patients who require oral endotracheal intubation. Participants will be assessed based on specific criteria indicating a higher likelihood of difficult intubation.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Louisville School of Medicine
  Louisville, Kentucky, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Reiner Lenhardt, MD
• Email: Rainer.lenhardt@louisville.edu
• Phone: 502-852-3122

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.