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Completed

NCT Number: NCT06505850

Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, 114, Taiwan

About this study

Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation

Exclusion criteria

  • Age < 18 years or age > 80 years
  • Diseases or anatomic abnormalities in the neck, larynx, or pharynx
  • Combined surgery such as breast reconstruction
  • Active pulmonary disease
  • Morbid obesity (body mass index ≥ 40 kg/m2)
  • Pregnancy
  • Refusal to join the study

Treatment and study plan

Tapered-shaped cuff tracheal tube

Device

Tracheal intubation with a tapered-shaped cuff tube

Cylindrical-shaped cuff tracheal tube

Device

Tracheal intubation with a cylindrical-shaped cuff tube

Primary outcomes

  1. The incidence of postoperative sore throat

    Time frame: Postoperative 48 hours

  2. The severity of postoperative sore throat

    Time frame: Postoperative 48 hours

    1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: The end of surgery

  2. Intraoperative propofol consumption

    Time frame: The end of surgery

  3. Intraoperative rocuronium consumption

    Time frame: The end of surgery

  4. The degree of subglottic injury

    Time frame: Intraoperative (The time point at extubation)

    None: no subglottic injury; mild: mucosal hyperemia and edema and/or slight submucosal hematoma; moderate: moderate submucosal hematoma; severe: mucosal laceration and/or mucosal bleeding)

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes With Different Cuff Shapes in Breast Cancer Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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