Postoperative Sore ThroatNCT07511998
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)
A study testing TaperGuard™ Endotracheal Tube in people with Postoperative Sore Throat and Hoarseness, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Postoperative Sore Throat, Hoarseness
- What is being tested?
- TaperGuard™ Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2025to 12 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, Daegu, 41404
About this study
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.
Read the detailed description
- Background and Rationale Postoperative sore throat (POST) is a frequent complication following general anesthesia with endotracheal intubation, significantly impacting patient satisfaction. The mechanism of POST involves localized trauma and subsequent inflammatory responses or mucosal edema caused by the endotracheal tube (ETT) and its cuff. The TaperGuard™ ETT, designed with a tapered polyvinyl chloride cuff, aims to reduce micro-aspiration compared to conventional cylindrical ETTs. Previous studies have demonstrated that the TaperGuard™ ETT results in a lower incidence of POST than cylindrical ETTs. Additionally, while research on cylindrical ETTs has shown that a smaller inner diameter (ID) correlates with a lower incidence of POST, this effect has not been specifically validated for the TaperGuard™ ETT. This study aims to evaluate whether using a one-size smaller TaperGuard™ ETT (ID 6.0 mm) further reduces POST compared to a standard size (ID 7.0 mm) in female patients.
- Study Population and Randomization Female patients aged 19 to 70 with an ASA physical status of I-III scheduled for surgery under general anesthesia in the supine or lithotomy position will be enrolled. Participants will be randomly assigned to either the Control Group (Group C: ID 7.0 mm) or the Small Group (Group S: ID 6.0 mm) using a computer-generated random number sequence.
- 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.
- Emergence and Recovery Five minutes before the end of surgery, fentanyl (50 mcg) will be administered intravenously. Upon completion of surgery, sevoflurane and remifentanil will be discontinued, and sugammadex (100 mg) will be administered for neuromuscular blockade reversal. Extubation will be performed when the patient's spontaneous tidal volume exceeds 200 ml and they follow verbal commands to open their eyes.
- Outcome Assessment A blinded co-investigator, who is not involved in the anesthesia administration, will assess the presence and severity of POST and hoarseness. Assessments will be conducted at four time points: immediately upon arrival at the Post-Anesthesia Care Unit (PACU), and at 1, 6, and 24 hours postoperatively. The severity of POST will be recorded using an 11-point Numerical Rating Scale (NRS).
- Conditions
- Postoperative Sore Throat, Hoarseness
- Being tested
- TaperGuard™ Endotracheal Tube
- Keywords
- Endotracheal Intubation, TaperGuard™ Endotracheal Tube, Inner Diameter of Endotracheal Tube, Intubation Complications, Airway Management
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaperGuard™ Endotracheal TubeDevice
A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Standard ID TaperGuard™ ETT (TaperGuard ETT ID 7.0mm) | Active comparator | atients in this group will be intubated using a TaperGuard™ endotracheal tube with a standard inner diameter of 7.0 mm. Receives: Device: TaperGuard™ Endotracheal Tube |
| Small Group S (TaperGuard ETT ID 6.0mm) | Experimental | Patients intubated with TaperGuard™ ETT ID 6.0mm Receives: Device: TaperGuard™ Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Sore Throat (POST)
The presence or absence of sore throat (Yes/No) will be assessed by a blinded co-investigator
Measured: 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)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start26 Feb 2025
- Primary completion27 Feb 2025
- Study completion12 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Chilgok Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyoung Oh, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511998
- Sponsor's protocol ID
- 2023-06-015
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available.
Publications
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.
PubMed 24124452Chang 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.
PubMed 28368938
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07511998
- Acronym / sponsor ID
- 2023-06-015
- Conditions
- Postoperative Sore Throat, Hoarseness
- Keywords
- Endotracheal Intubation, TaperGuard™ Endotracheal Tube, Inner Diameter of Endotracheal Tube, Intubation Complications, Airway Management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Kyungpook National University Chilgok HospitalUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 12 May 2026 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background and Rationale Postoperative sore throat (POST) is a frequent complication following general anesthesia with endotracheal intubation, significantly impacting patient satisfaction. The mechanism of POST involves localized trauma and subsequent inflammatory responses or mucosal edema caused by the endotracheal tube (ETT) and its cuff. The TaperGuard™ ETT, designed with a tapered polyvinyl chloride cuff, aims to reduce micro-aspiration compared to conventional cylindrical ETTs. Previous studies have demonstrated that the TaperGuard™ ETT results in a lower incidence of POST than cylindrical ETTs. Additionally, while research on cylindrical ETTs has shown that a smaller inner diameter (ID) correlates with a lower incidence of POST, this effect has not been specifically validated for the TaperGuard™ ETT. This study aims to evaluate whether using a one-size smaller TaperGuard™ ETT (ID 6.0 mm) further reduces POST compared to a standard size (ID 7.0 mm) in female patients.
- Study Population and Randomization Female patients aged 19 to 70 with an ASA physical status of I-III scheduled for surgery under general anesthesia in the supine or lithotomy position will be enrolled. Participants will be randomly assigned to either the Control Group (Group C: ID 7.0 mm) or the Small Group (Group S: ID 6.0 mm) using a computer-generated random number sequence.
- 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.
- Emergence and Recovery Five minutes before the end of surgery, fentanyl (50 mcg) will be administered intravenously. Upon completion of surgery, sevoflurane and remifentanil will be discontinued, and sugammadex (100 mg) will be administered for neuromuscular blockade reversal. Extubation will be performed when the patient's spontaneous tidal volume exceeds 200 ml and they follow verbal commands to open their eyes.
- Outcome Assessment A blinded co-investigator, who is not involved in the anesthesia administration, will assess the presence and severity of POST and hoarseness. Assessments will be conducted at four time points: immediately upon arrival at the Post-Anesthesia Care Unit (PACU), and at 1, 6, and 24 hours postoperatively. The severity of POST will be recorded using an 11-point Numerical Rating Scale (NRS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ID TaperGuard™ ETT (TaperGuard ETT ID 7.0mm) | Active comparator | Device: TaperGuard™ Endotracheal Tubeatients in this group will be intubated using a TaperGuard™ endotracheal tube with a standard inner diameter of 7.0 mm. |
| Small Group S (TaperGuard ETT ID 6.0mm) | Experimental | Device: TaperGuard™ Endotracheal TubePatients intubated with TaperGuard™ ETT ID 6.0mm |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaperGuard™ Endotracheal TubeA tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O | Device | Small Group S (TaperGuard ETT ID 6.0mm), Standard ID TaperGuard™ ETT (TaperGuard ETT ID 7.0mm) |
Primary outcome
Incidence of Postoperative Sore Throat (POST)
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)
The presence or absence of sore throat (Yes/No) will be assessed by a blinded co-investigator
2 secondary outcomes
Severity of Postoperative Sore Throat
Time frame: Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Incidence of Hoarseness
Time frame: Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Results publication: PubMed 24124452Hu 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.
- Results publication: PubMed 28368938Chang 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaperGuard™ Endotracheal Tube in people with Postoperative Sore Throat and Hoarseness, run by Kyungpook National University Chilgok Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Sore Throat (POST) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07511998, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.