Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation (DA-TCI)

University of Louisville (UOFL)

Status: Enrolling

Conditions: Predicted Difficult Airway

Treatments: Device: video-laryngoscope and GlideRite Rigid Stylet; Device: video-laryngoscope and TCI Articulating Introducer Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04866472

IRB20.0744

Details and patient eligibility

About

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.

Full description

Multi-Centered, Prospective, Randomized, Control Trial

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Video Laryngoscope and GlideRite Ridgid Stylet

Other group

Treatment:

Device: video-laryngoscope and GlideRite Rigid Stylet

Video Laryngoscope and TCI Articulating Introducer

Experimental group

Treatment:

Device: video-laryngoscope and TCI Articulating Introducer Device