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Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06505850
Enrollment
176
Registered
2024-07-17
Start date
2024-07-22
Completion date
2025-01-03
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Endotracheal Tube Cuff, Postoperative Sore Throat, Subglottic Airway Injury

Keywords

Endotracheal tube cuff, Postoperative sore throat, Subglottic airway injury, Breast Cancer

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.

Interventions

DEVICECylindrical-shaped cuff tracheal tube

Tracheal intubation with a cylindrical-shaped cuff tube

DEVICETapered-shaped cuff tracheal tube

Tracheal intubation with a tapered-shaped cuff tube

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative sore throatPostoperative 48 hours
The severity of postoperative sore throatPostoperative 48 hours1, 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

MeasureTime frameDescription
Intraoperative fentanyl consumptionThe end of surgery
Intraoperative propofol consumptionThe end of surgery
Intraoperative rocuronium consumptionThe end of surgery
The degree of subglottic injuryIntraoperative (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)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026