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)
Enrolling by invitation · Not applicable
Conditions studied: Postoperative Sore Throat, Hoarseness
In brief
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.
Key facts
- Study ID
- NCT07511998
- Run by
- Kyungpook National University Chilgok Hospital
- People needed
- 246
- Starts
- 2025-02-26
- Expected to finish
- 2026-05-12
- Last updated by the study team
- 2026-04-06
Who can join
Age: 20 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kyungpook National University Chilgok Hospital — Daegu, Daegu, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.