Recruiting

VLS vs. TCI

Sponsor:

University of Louisville

Code:

NCT04866472

Conditions

Predicted Difficult Airway

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

video-laryngoscope and GlideRite Rigid Stylet

video-laryngoscope and TCI Articulating Introducer Device

Study Details

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.

Conditions

Predicted Difficult Airway

Study ID

NCT04866472

Start date

Apr 26, 2022

Status verified date

Feb, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Video Laryngoscope and GlideRite Ridgid Stylet

experimental: Video Laryngoscope and TCI Articulating Introducer

Interventions

video-laryngoscope and GlideRite Rigid Stylet

Once subject is in the operating room, standard monitoring will be instituted including nerve stimulator. Induction will follow standard practice.Once full muscle relaxation is confirmed with a train of four of 0/4 laryngoscopy will be preformed using a video-laryngoscope (VLS) with a #3 blade for women and a #4 blade men. Endotracheal intubation will be performed using a #7 endotracheal tube in women and # 8 in men using the GlideRite Rigid Stylet. The stylet will be shaped to the curvature of the blade of the VLS and lubricated with a water-based lubricant. After successful tracheal intubation the circuit will be connected and ventilation confirmed with capnography and auscultation.

video-laryngoscope and TCI Articulating Introducer Device

In the operating room, standard monitoring will be instituted including nerve simulator. Induction will follow standard practice. Once full muscle relaxation is achieved (train of four of 0/4) laryngoscopy will be performed using a video-laryngoscope (VLS) using a #3 blade in women and a #4 blade in men. A #7 endotracheal tube will be used for women and a #8 for men. Endotracheal intubation will be performed by placing the tube on the back of the TCI articulating introducer, after shaft is lubricated with a water based lubricant. The tip of the TCI articulating introducer will be maneuvered into the trachea and advanced until the green zone of the introducer shaft is adjacent to the glottis. The handle of the articulating introducer will then be removed and the ETT will be advanced over the articulating introducer and into the trachea via Seldinger's technique. Once in place the respiratory circuit will be connected and confirmed with capnography and auscultation.

Primary outcome measure

  • Time to successful intubation using a combination of video-laryngoscope and TCI Articulating Device will be equilivant to intubation success usinging a combination of video-laryngoscope and GlideRite Rigid Stylet [ Time Frame: time measured in seconds with an estimated time of 30 to 120 seconds from the start of intubation to endotracheal tube placement verified by CO2 ]

Central Contacts and Locations

Central contacts

Reiner Lenhardt, MD

502-852-3122Rainer.lenhardt@louisville.edu

Emily Drennan, MD

801-581-6393emily.drennan@hsc.utah.edu

Locations

University of Louisville School of Medicine

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Rainer Lenhardt, MD MBA

502-852-3122rainer.lenhardt@louisville.edu

Ozan Akca, MD

502-852-5851ozan.akca@louisville.edu

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Elizabeth Cooke, RN

502-852-5851eacook02@louisville.edu

Principal Investigator:

Rainer Lenhardt, M.D.

More Information

Sponsor

University of Louisville

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-02-20.