Clinical trial NCT05383417: No Post Intubation Laryngeal Symptoms
Official title: Endotracheal Tube Clip for Prevention of Post Intubation Laryngeal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore-throat
Dysphonia
Dysphagia
Intubation Complication
Anesthesia Intubation Complication
Anesthesia Morbidity
Anesthesia Complication
Anesthesia; Adverse Effect
Anesthesia; Reaction
Throat Disorder
Throat; Wound
Throat Injury
Keywords: Endotracheal tube
Anesthesia
Sore throat
Throat pain
Dysphonia
Dysphagia
Throat injury
General anesthesia
Intubation
Endotracheal intubation
Breathing tube
Odynophonia
Odynophagia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sore throat on a visual analog scale from 0 (no sore throat) to 10 (worst possible sore throat)
timeFrame: Baseline to 1 week after intervention
measure: Change in voice on a visual analog scale from 0 (no voice change) to 10 (most severe voice change)
timeFrame: Baseline to 1 week after intervention
measure: Difficulty swallowing on a visual analog scale from 0 (no difficulty swallowing) to 10 (complete inability to swallow)
timeFrame: Baseline to 1 week after intervention
measure: Pain in the mouth on a visual analog scale from 0 (no mouth pain) to 10 (worst possible mouth pain)
timeFrame: Baseline to 1 week after intervention
measure: Difficulty talking on a visual analog scale from 0 (no difficulty talking) to 10 (complete inability to talk)
timeFrame: Baseline to 1 week after intervention
measure: Pain in the neck/chest on a visual analog scale from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain)
timeFrame: Baseline to 1 week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
Study officials:
affiliation: UC San Diego Health
name: Andrew Vahabzadeh-Hagh, MD
role: PRINCIPAL_INVESTIGATOR
References: