NCT07511998|Enrolling By InvitationFDA Device
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Sponsor study identifier
interventional
246
1 country
1
Study Start
February 26, 2025
Actual (reported)Primary Completion
February 27, 2025
Actual (reported)Study Completion
May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2025
Actual (reported)February 27, 2025
Actual (reported)March 30, 2026
Actual (reported)April 6, 2026
Actual (reported)May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of Postoperative Sore Throat (POST)
The presence or absence of sore throat (Yes/No) will be assessed by a blinded co-investigator
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)
Severity of Postoperative Sore Throat
Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Incidence of Hoarseness
Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
atients in this group will be intubated using a TaperGuard™ endotracheal tube with a standard inner diameter of 7.0 mm.
Patients intubated with TaperGuard™ ETT ID 6.0mm
A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kyungpook National University Chilgok Hospital
Daegu, Daegu, 41404, South Korea
Hu B, Bao R, Wang X, Liu S, Tao T, Xie Q, Yu X, Li J, Bo L, Deng X. The size of endotracheal tube and sore throat after surgery: a systematic review and meta-analysis. PLoS One. 2013 Oct 4;8(10):e74467. doi: 10.1371/journal.pone.0074467. eCollection 2013.
Chang JE, Kim H, Han SH, Lee JM, Ji S, Hwang JY. Effect of Endotracheal Tube Cuff Shape on Postoperative Sore Throat After Endotracheal Intubation. Anesth Analg. 2017 Oct;125(4):1240-1245. doi: 10.1213/ANE.0000000000001933.
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
February 26, 2025
Actual (reported)Primary Completion
February 27, 2025
Actual (reported)Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat
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Study Completion
May 12, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 6, 2026
Record last verified: 2026-03
De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available.
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Source: ClinicalTrials.gov.
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