CompletedNot Applicable

No Post Intubation Laryngeal Symptoms

United States100 participantsStarted 2022-11-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: 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)

Timeframe: Baseline to 1 week after intervention

Trial details

NCT IDNCT05383417

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-21

Results submitted2024-09-22

View on ClinicalTrials.gov More Sore-throat trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: Baseline to 1 week after intervention

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

Timeframe: 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)

Timeframe: Baseline to 1 week after intervention