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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)

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07511998
Lead Sponsor Kyungpook National University Chilgok Hospital
Conditions
(from sponsor)
Postoperative Sore Throat, Hoarseness
Related terms Hoarseness
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov