RECRUITING

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

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Conditions

Predicted Difficult Airway

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2022-04-26
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04866472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients requiring oral endotracheal intubation
  2. * Age 18 years or older
  3. * Group A Criteria (need only one of the following criteria)
  4. 1. History of difficult intubation
  5. 2. History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery
  6. 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)
  7. 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
  8. 3. Oropharyngeal view: modified Mallampati scale of 3 or 4
  9. 4. Mouth opening \< 4 cm
  10. 5. Protruding upper teeth (severe overbite)
  11. 6. History of radiation to the neck
  12. 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)
  13. 8. Body Mass Index (BMI) \>35 kg/m2
  14. 9. Neck circumference .\> 40 cm in females and 43 cm in males measured at the thyroid cartilage
  15. 10. Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Reiner Lenhardt, MD
CONTACT
502-852-3122
Rainer.lenhardt@louisville.edu
Emily Drennan, MD
CONTACT
801-581-6393
emily.drennan@hsc.utah.edu

Study Locations (Sites)

University of Louisville School of Medicine
Louisville, Kentucky, 40202
United States
University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26
Study Completion Date2024-08

Study Record Updates

Study Start Date2022-04-26
Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

  • Predicted Difficult Airway