Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Postoperative Sore Throat; Breast Cancer; Subglottic Airway Injury; Endotracheal Tube Cuff
• Interventions: Device: Cylindrical-shaped cuff tracheal tube; Device: Tapered-shaped cuff tracheal tube

• Registration Number: NCT06505850
• Lead Sponsor: Tri-Service General Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-17
• Study Start: 2024-07-22
• Primary Completion: 2024-12-13
• Study Completion: 2025-01-03
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cylindrical-shaped cuff ETT group	Cylindrical-shaped cuff tracheal tube	A cylindrical-shaped cuff tube was used to intubate for general anesthesia
Tapered-shaped cuff ETT group	Tapered-shaped cuff tracheal tube	A tapered-shaped cuff tube was used to intubate for general anesthesia

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative sore throat	Postoperative 48 hours
The severity of postoperative sore throat	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 Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	The end of surgery
Intraoperative propofol consumption	The end of surgery
Intraoperative rocuronium consumption	The end of surgery
The degree of subglottic injury	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)

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan