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

NCT04866472 | Recruiting FDA Device

• 1 other identifier: IRB20.0744
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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

Outcome Measures

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

  successful intubation

  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

Secondary Outcomes (4)

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

  completed immediately after subject intubation

• Need to use a maneuver called "corkscrew" ETT to pass glottis

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

• Blood in airway

  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

• Time to intubate using either control or intervention

  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

Study Arms (2)

Video Laryngoscope and GlideRite Ridgid Stylet

OTHER

Device: video-laryngoscope and GlideRite Rigid Stylet

Video Laryngoscope and TCI Articulating Introducer

EXPERIMENTAL

Device: video-laryngoscope and TCI Articulating Introducer Device

Interventions

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 GlideRite Ridgid Stylet

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.

Video Laryngoscope and TCI Articulating Introducer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing

Sponsors & Collaborators

• University of Louisville: lead
• University of Utah: collaborator

Study Sites (2)

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (4)

• Mort TC. The incidence and risk factors for cardiac arrest during emergency tracheal intubation: a justification for incorporating the ASA Guidelines in the remote location. J Clin Anesth. 2004 Nov;16(7):508-16. doi: 10.1016/j.jclinane.2004.01.007.

  PMID: 15590254 BACKGROUND

• Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.

  PMID: 23574475 BACKGROUND

• Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. doi: 10.1097/00000542-199005000-00010.

  PMID: 2339799 BACKGROUND

• Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.

  PMID: 24842175 BACKGROUND

Central Study Contacts

Reiner Lenhardt, MD

CONTACT

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

Emily Drennan, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, University of Louisville, School of Medicine

Model Details: Randomization to Control: Video-Laryngoscope and GlideRite Rigid Stylet vs Intervention: Video-Laryngoscope with TCI Articulating Device

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 29, 2021
• Study Start: April 26, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)