Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Andrew Vahabzadeh-Hagh, MD
Headshot of Andrew Vahabzadeh-Hagh
Andrew Vahabzadeh-Hagh

Description

Summary

The purpose of the study is to test a novel endotracheal tube support device that reduces pressure of the tube on the voice box for prevention of post intubation laryngeal symptoms including sore throat, change in voice and trouble swallowing.

Official Title

Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms

Details

Single center randomized controlled trial with 100 subjects who will be intubated for already planned surgeries. The participants will be randomized into the control group or the clip group. The clip group will have a small clip (the endotracheal tube support device) placed on the endotracheal tube to reduce the pressure on the vocal cords and larynx. This endotracheal tube support device is made from a FDA approved biocompatible material. The control group subjects will undergo their planned procedure with no intervention during intubation. The clip group will undergo their planned procedure as normal but with the endotracheal tube support device placed on the endotracheal tube by the assigned anesthesia attending physician. The clip is placed once the tube is secured and the ventilator circuit is connected. While extubating the patient, the endotracheal tube will be removed with the clip attached and a picture of the tube will be taken to record the clip location. Before the planned procedure, the investigators will survey the participants to get a baseline for any pre-existing laryngeal symptoms. The same survey will be administered after the procedure when the participants are awake and alert just prior to discharge, 24 hours, 48 hours, and 1 week after the procedure. The survey will ask the participant to indicate "yes" or "no" for whether they are experiencing a sore throat, throat pain, oral pain, difficulty speaking, difficulty swallowing, changes in their voice, pain while speaking, and pain while swallowing. If they have indicated "yes" for any of the symptoms, the participants will also be asked to mark the severity on a visual analog scale from 1 to 10. Other data points will also be collected in this study that are related to the intubation and participant's airway. The investigators will record the total time of the procedure and the length of time the clip is placed on the endotracheal tube. For each participant in the clip group, the investigators will also record the time it takes to place the clip on the endotracheal tube. Each participant's airway will be evaluated, and the investigators will record the thyromental distance, Mallampati score, history of difficult intubation, and the size of the endotracheal tube used. Lastly, data from each participant's intubation will be collected including number of attempts before successful intubation, incidence of dental injury, incidence of lip injury, laryngeal view on Cormack-Lehane scale, and any noted trauma upon extubation. Lastly, the investigators will have the anesthesiologists recruited for the study fill out a modified National Aeronautics and Space Administration (NASA) Task Load Index (TLX) form to evaluate the end-user experience for the device.

Keywords

Sore-throat Dysphonia Dysphagia Intubation Complication Anesthesia Intubation Complication Anesthesia Morbidity Anesthesia Complication Anesthesia; Adverse Effect Anesthesia; Reaction Throat Disorder Throat; Wound Throat Injury Endotracheal tube Anesthesia Sore throat Throat pain General anesthesia Intubation Endotracheal intubation Breathing tube Odynophonia Odynophagia Pharyngitis Deglutition Disorders Hoarseness EndoClip

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient undergoing general endotracheal anesthesia with an endotracheal tube
  • Patient is not undergoing a procedure in the head and neck region

You CAN'T join if...

  • Patient with pre-existing severe sore throat, voice change, or trouble swallowing
  • Patient undergoing surgery in the head and neck region

Location

  • UC San Diego Health accepting new patients
    La Jolla California 92037-7895 United States

Lead Scientist at UCSD

  • Andrew Vahabzadeh-Hagh, MD
    Assistant Clinical Professor, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 31 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05383417
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated