Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

January 4, 2025 updated by: Wei-Cheng Tseng, Tri-Service General Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tapered-shaped cuff ETT group
A tapered-shaped cuff tube was used to intubate for general anesthesia
Device: Tapered-shaped cuff tracheal tube
Tracheal intubation with a tapered-shaped cuff tube
Active Comparator: Cylindrical-shaped cuff ETT group
A cylindrical-shaped cuff tube was used to intubate for general anesthesia
Device: Cylindrical-shaped cuff tracheal tube
Tracheal intubation with a cylindrical-shaped cuff tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative sore throat
Time Frame: Postoperative 48 hours
Postoperative 48 hours
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)
Postoperative 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative fentanyl consumption
Time Frame: The end of surgery
The end of surgery
Intraoperative propofol consumption
Time Frame: The end of surgery
The end of surgery
Intraoperative rocuronium consumption
Time Frame: The end of surgery
The end of surgery
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)
Intraoperative (The time point at extubation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

January 3, 2025

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A202405086_V3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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