No Post Intubation Laryngeal Symptoms

NCT05383417 | Completed Results FDA Device

• 1 other identifier: 800842
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• Sore Throat on a Scale From 0 (no Sore Throat) to 10 (Worst Possible Sore Throat)

  Subjects will indicate whether they are experiencing a sore throat or throat discomfort on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no sore throat) to 10 (worst possible sore throat). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Change in Voice on a Scale From 0 (no Voice Change) to 10 (Most Severe Voice Change)

  Subjects will indicate whether they are experiencing a change in voice (i.e. deep and/or hoarse voice, worse than their usual voice quality) on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no voice change) to 10 (most severe voice change). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Difficulty Swallowing on a Scale From 0 (no Difficulty Swallowing) to 10 (Complete Inability to Swallow)

  Subjects will indicate whether they are experiencing difficulty swallowing on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty swallowing) to 10 (complete inability to swallow). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Pain in the Mouth on a Scale From 0 (no Mouth Pain) to 10 (Worst Possible Mouth Pain)

  Subjects will indicate whether they are experiencing mouth pain on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no mouth pain) to 10 (worst possible mouth pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Difficulty Talking on a Scale From 0 (no Difficulty Talking) to 10 (Complete Inability to Talk)

  Subjects will indicate whether they are experiencing difficulty talking on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no difficulty talking) to 10 (complete inability to talk). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Pain in the Neck/Chest on a Scale From 0 (no Neck/Chest Pain) to 10 (Worst Possible Neck/Chest Pain)

  Subjects will indicate whether they are experiencing pain in the anterior or low region of the neck and/or chest on a questionnaire. If they indicate 'yes' they will be asked to mark the severity of their symptoms on a scale ranging from 0 (no neck/chest pain) to 10 (worst possible neck/chest pain). Participants will be asked to report on their symptoms prior to intubation, after intubation on the day of discharge, 24 hours after intubation, 48 hours after intubation, and 1 week after intubation. Subjects that report baseline (prior to intubation) throat symptoms are excluded from the study.

  Baseline to 1 week after intervention

• Patients With Post Operative Mouth Pain

  Patients with post operative mouth pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

• Patients With Post Operative Sore Throat

  Patients with post operative sore throat during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

• Patients With Post Operative Neck/Chest Pain

  Patients with post operative neck/chest pain during the first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

• Patients With Post Operative Voice Change

  Patients with post operative voice change over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

• Patients With Post Operative Difficulty Talking

  Patients with post operative difficulty talking over the post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

• Patients With Post Operative Difficulty Swallowing

  Patients with post operative difficulty swallowing over there first post operative 7 days. Each subject was to complete a survey at each of 4 time points (total 4 x 100 = 400 possible total surveys, 200 per group). All patients completed at least one survey during the study. Not all subjects completed the surveys at each time point. Therefore the number of units analyzed is less than 200 for each group below.

  7 days

Study Arms (2)

EndoClip

EXPERIMENTAL

Clip applied to endotracheal tube.

Device: EndoClip

No Clip

NO INTERVENTION

No clip applied to endotracheal tube.

Interventions

EndoClip DEVICE

Clip attached to mid portion of the endotracheal tube.

Also known as: Endotracheal tube clip

EndoClip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Health

La Jolla, California, 92037-7895, United States

Location

MeSH Terms

Conditions

Pharyngitis; Dysphonia; Deglutition Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Laryngeal Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Andrew Vahabzadeh-Hagh
• Organization: University of California San Diego Health

avahabz@health.ucsd.edu

858-249-4070

Study Officials

• Andrew Vahabzadeh-Hagh, MD

  UC San Diego Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will not be aware of their treatment arm. Investigator and Care Provider will be aware of treatment are but data analysis (outcomes assessor) will be blinded to treatment groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: 2 arm parallel trial where one group will receive the endotracheal tube clip during general endotracheal anesthesia and the other group will not.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 20, 2022
• Study Start: November 8, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)