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)

Overview

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

1. 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. 2. 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. 3. 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. 4. 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. 5. 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).

Interventions

• Device TaperGuard™ Endotracheal Tube
  A tapered-cuff ETT. Cuff pressure is maintained at 22 cmH2O

Primary outcome measures

• 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)]

Secondary outcome measures (2)

• 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).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

South Korea · 1 center

• Kyungpook National University Chilgok Hospital — Daegu

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. PMID 24124452
• 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. PMID 28368938

Identifiers

NCT: NCT07511998 · 2023-06-015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗