Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Description

Multi-Centered, Prospective, Randomized, Control Trial

Eligibility

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 details
    Predicted Difficult Airway

NCT04866472

University of Louisville

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.