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Postoperative sore throat (POST) is a common complication following general anesthesia involving endotracheal intubation, often leading to decreased patient satisfaction. The TaperGuardâ„¢ 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 TaperGuardâ„¢ ETT.
This study aims to compare the incidence of POST between a standard-sized TaperGuardâ„¢ ETT (ID 7.0 mm) and a smaller-sized TaperGuardâ„¢ ETT (ID 6.0 mm) in female patients. The investigators hypothesize that using a smaller ID TaperGuardâ„¢ 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.
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 TaperGuardâ„¢ ETT, designed with a tapered polyvinyl chloride cuff, aims to reduce micro-aspiration compared to conventional cylindrical ETTs. Previous studies have demonstrated that the TaperGuardâ„¢ 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 TaperGuardâ„¢ ETT. This study aims to evaluate whether using a one-size smaller TaperGuardâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard ID TaperGuardâ„¢ ETT (TaperGuard ETT ID 7.0mm) | Active Comparator | atients in this group will be intubated using a TaperGuardâ„¢ endotracheal tube with a standard inner diameter of 7.0 mm. |
|
| Small Group S (TaperGuard ETT ID 6.0mm) | Experimental | Patients intubated with TaperGuardâ„¢ ETT ID 6.0mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TaperGuardâ„¢ Endotracheal Tube | Device | A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h). |
| Incidence of Hoarseness |
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Inclusion Criteria:
Exclusion Criteria:
Only female patients are included in this study to ensure a homogeneous study population and to minimize confounding factors related to gender-specific differences in airway anatomy and the incidence of postoperative sore throat (POST). This approach allows for a direct comparison with previous clinical data that established the standard endotracheal tube (ETT) size (ID 7.0 mm) for female adults as a reference point for investigating the effects of a smaller ETT size.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | Daegu | 41404 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24124452 | Result | 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. | |
| 28368938 | Result | 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. |
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De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available.
Beginning 6 months and ending 3 years following article publication.
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.
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The presence or absence of hoarseness (Yes/No) will be recorded by a blinded investigator. |
| Up to 24 hours postoperatively (at PACU arrival, 1h, 6h, and 24h). |
| ID | Term |
|---|---|
| D006685 | Hoarseness |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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