Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

Trial Title: Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

NCT ID: NCT06505850

Condition: Breast Cancer
Postoperative Sore Throat
Subglottic Airway Injury
Endotracheal Tube Cuff

Conditions: Official terms:
Pharyngitis
Breast Neoplasms

Conditions: Keywords:
Endotracheal tube cuff
Postoperative sore throat
Subglottic airway injury
Breast Cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Tapered-shaped cuff tracheal tube
Description: Tracheal intubation with a tapered-shaped cuff tube
Arm group label: Tapered-shaped cuff ETT group

Intervention type: Device
Intervention name: Cylindrical-shaped cuff tracheal tube
Description: Tracheal intubation with a cylindrical-shaped cuff tube
Arm group label: Cylindrical-shaped cuff ETT group

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

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Gender based: Yes

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

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: July 18, 2024

Completion date: June 30, 2025

Lead sponsor:
Agency: Tri-Service General Hospital
Agency class: Other

Source: Tri-Service General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06505850