Comparing two devices for difficult airway intubation

Comparison of Video Laryngoscope (VLS) With GlideRite Ridge Stylet vs Video Laryngoscope With the TCI Articulating Indroducer for Endotracheal Intubation in Predicted Difficult Airways. A Prospective Randomized Control Trial

This study is testing if a new device for helping doctors intubate patients with difficult airways works as well as a standard device when used with a video camera.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Louisville (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Louisville, Kentucky and 1 other locations)
• Trial ID: NCT04866472 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a history of difficult intubation or specific anatomical criteria indicating potential challenges.

Not a fit: Patients without any history of difficult intubation or those who do not meet the anatomical criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and success rates of intubation in patients with predicted difficult airways.

How similar studies have performed: Other studies have explored similar approaches in difficult airway management, but the specific use of the TCI Articulating Introducer Device is relatively novel.

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

Where this trial is running

Louisville, Kentucky and 1 other locations

• 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

Conditions: Predicted Difficult Airway