Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04866472

Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Predicted Difficult Airway

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville, Louisville, Kentucky, United States

Loading trial locations.

About this study

Multi-Centered, Prospective, Randomized, Control Trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring oral endotracheal intubation
  • Age 18 years or older
  • Group A Criteria (need only one of the following criteria)
  • History of difficult intubation
  • History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery

Group B Criteria (need three or more of the following)

  • 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)
  • 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
  • Oropharyngeal view: modified Mallampati scale of 3 or 4
  • Mouth opening < 4 cm
  • Protruding upper teeth (severe overbite)
  • History of radiation to the neck
  • 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)
  • Body Mass Index (BMI) >35 kg/m2
  • Neck circumference .> 40 cm in females and 43 cm in males measured at the thyroid cartilage
  • 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

Treatment and study plan

video-laryngoscope and GlideRite Rigid Stylet

Device

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

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 outcomes

  1. 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

    successful intubation

Secondary outcomes

  1. Ease of intubation using TCI Articulating Device as compaired to GlideRite Rigid Stylet as rated by provider

    Time frame: completed immediately after subject intubation

    completion by provider of "Ease of Intubation" visual score scale measured from 0 to 100, with 0 being impossible intubation and 100 perfectly easy intubation

  2. Need to use a maneuver called "corkscrew" ETT to pass glottis

    Time frame: Period in seconds with an estimated time of 30 to 120 seconds between start of intubation procedure to ETT placement or failure to place

    provider confirms use of "corkscrew" maneuver during or after intubation, scale as yes or no

  3. Blood in airway

    Time frame: Period in seconds with an estimated time of 30 to 120 seconds between start of use of TCI Articulating Device to placement of ETT tube or failure to place

    Provider reports blood in airway after the end of the intubation

  4. Time to intubate using either control or intervention

    Time frame: Time measured in seconds, with an estimated time of 30 to 120 seconds, from time of first view of glottis to time ETT placement or failure to place

    Time from first view of glottis to ETT placement or failure to place, up to three attempts using each technique

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Drennan, MD

CONTACT

[email protected]

801-581-6393

Reiner Lenhardt, MD

CONTACT

[email protected]

502-852-3122

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • University of Utah

Registry information

Official study title

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

Acronym: DA-TCI

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 29, 2021
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.