A Randomized, Comparative, Controlled Study of Differences in the Incidence of Postoperative Sore… (NCT07511998) | Clinical Trial Compass
By InvitationNot Applicable
A Randomized, Comparative, Controlled Study of Differences in the Incidence of Postoperative Sore Throat (POST) by Inner Diameter Size of the TaperGuardTM Endotracheal Tube (ETT)
South Korea246 participantsStarted 2025-02-26
Plain-language summary
Postoperative sore throat (POST) is a common complication following general anesthesia involving endotracheal intubation, often leading to decreased patient satisfaction. The TaperGuard™ endotracheal tube (ETT) features a tapered-shaped cuff designed to reduce micro-aspiration and has been shown to result in a lower incidence of POST compared to conventional cylindrical ETTs. While previous studies using standard cylindrical ETTs suggested that a smaller inner diameter (ID) reduces the risk of POST, this relationship has not been fully established specifically for the TaperGuard™ ETT.
This study aims to compare the incidence of POST between a standard-sized TaperGuard™ ETT (ID 7.0 mm) and a smaller-sized TaperGuard™ ETT (ID 6.0 mm) in female patients. The investigators hypothesize that using a smaller ID TaperGuard™ ETT will significantly reduce the occurrence of POST within 24 hours after surgery.
Patients will be randomly assigned to either the control group (ID 7.0 mm) or the small group (ID 6.0 mm). Throughout the procedure, cuff pressure will be strictly maintained at 22 cmH2O to minimize mucosal damage. The primary outcome is the presence of sore throat, and secondary outcomes include the severity of the pain and the incidence of hoarseness at several time points up to 24 hours postoperatively.
Who can participate
Age range
20 Years – 70 Years
Sex
FEMALE
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:
* Female patients.
* Aged between 19 and 70 years.
* American Society of Anesthesiologists (ASA) physical status I, II, or III.
* Patients scheduled to undergo elective surgery under general anesthesia requiring endotracheal intubation.
* Patients undergoing surgery in the supine or lithotomy position.
* Patients who voluntarily provide written informed consent after receiving a full explanation of the study's purpose and procedures
Exclusion Criteria:
* Predicted difficult intubation.
* Confirmed diseases or anatomical abnormalities of the head and neck, including the pharynx and larynx.
* Presence of preoperative sore throat.
* Risk of pulmonary aspiration.
* Requirement for the prone position or other surgical positions where airway management with a TaperGuard™ ETT is difficult.
* Scheduled for head and neck surgery or other procedures where the use of a TaperGuard™ ETT is challenging.
* Potential pregnancy.
* Inability to provide informed consent or make a decision to participate after receiving the study explanation
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
1
Incidence of Postoperative Sore Throat (POST)
Timeframe: Up to 24 hours after surgery (Assessment time points: immediately upon arrival at the Post-Anesthesia Care Unit [PACU], and at 1, 6, and 24 hours postoperatively)
Trial details
NCT IDNCT07511998
SponsorKyungpook National University Chilgok Hospital