Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
University of Louisville
RECRUITING
Louisville
University of Louisville School of Medicine
RECRUITING
Louisville
Contact Information
Primary
Reiner Lenhardt, MD
Rainer.lenhardt@louisville.edu
502-852-3122
Backup
Emily Drennan, MD
emily.drennan@hsc.utah.edu
801-581-6393
Time Frame
Start Date: 2022-04-26
Estimated Completion Date: 2027-04
Participants
Target number of participants: 160
Treatments
Other: Video Laryngoscope and GlideRite Ridgid Stylet
Experimental: Video Laryngoscope and TCI Articulating Introducer
Related Therapeutic Areas
Sponsors
Leads: University of Louisville
Collaborators: University of Utah

This content was sourced from clinicaltrials.gov