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ENROLLING BY INVITATION
NCT07511998
NA

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)

Sponsor: Kyungpook National University Chilgok Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2025-02-26

Completion Date

2026-05-12

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DEVICE

TaperGuard™ Endotracheal Tube

A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O

Locations (1)

Kyungpook National University Chilgok Hospital

Daegu, Daegu, South Korea