An interventional study of TaperGuard™ Endotracheal Tube in Postoperative Sore Throat and Hoarseness, sponsored by Kyungpook National University Chilgok Hospital. Enrolling by invitation at 1 site in South Korea. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Kyungpook National University Chilgok Hospital · Not applicable, Interventional, and Other
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.
Anesthesia Protocol Induction: After 5 minutes of preoxygenation, anesthesia will be induced using intravenous lidocaine (40 mg), propofol (2 mg/kg), and rocuronium (0.8 mg/kg).
Intubation: Tracheal intubation will be performed using direct laryngoscopy. The ETT position will be confirmed via a fiberoptic bronchoscope to be 4 cm above the carina. The cuff will be inflated with air, and the pressure will be strictly adjusted to 22 cmH2O using a manometer.
Maintenance: Anesthesia will be maintained with sevoflurane (1.5-3.0%) and remifentanil (Target-Controlled Infusion, 2-3 ng/mL). Mechanical ventilation will be set to a tidal volume of 8 ml/kg and a respiratory rate of 10-12 cycles/min to target an EtCO2 of 30-35 mmHg.
52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.
This study's planned enrollment of 246 is above the median of 108 across 44 interventional studies indexed under Hoarseness.
Browse Hoarseness studies →Kyungpook National University Chilgok Hospital is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
atients in this group will be intubated using a TaperGuard™ endotracheal tube with a standard inner diameter of 7.0 mm.
Device: TaperGuard™ Endotracheal Tube
Patients intubated with TaperGuard™ ETT ID 6.0mm
Device: TaperGuard™ Endotracheal Tube
A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O
Incidence of Postoperative Sore Throat (POST)
The presence or absence of sore throat (Yes/No) will be assessed by a blinded co-investigator
Time frame: 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
The intensity of sore throat will be evaluated using an 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain.
Time frame: Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Incidence of Hoarseness
The presence or absence of hoarseness (Yes/No) will be recorded by a blinded investigator.
Time frame: Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Plan to share: Yes — De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 6 months and ending 3 years following article publication.
Access criteria: Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to the corresponding author.
Ran from Feb 2025 to primary completion in Feb 2025, 0 months.
Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 0 months is below that.
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Kyungpook National University Chilgok Hospital