Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

Tri-Service General Hospital

Status: Completed

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

Treatments: Device: Tapered-shaped cuff tracheal tube; Device: Cylindrical-shaped cuff tracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT06505850

A202405086_V3

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

176 participants in 2 patient groups

Tapered-shaped cuff ETT group

Experimental group

Description:

A tapered-shaped cuff tube was used to intubate for general anesthesia

Treatment:

Device: Tapered-shaped cuff tracheal tube

Cylindrical-shaped cuff ETT group

Active Comparator group

Description:

A cylindrical-shaped cuff tube was used to intubate for general anesthesia

Treatment:

Device: Cylindrical-shaped cuff tracheal tube