Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2025-01-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer Postoperative Sore Throat Subglottic Airway Injury Endotracheal Tube Cuff

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tapered-shaped cuff ETT group

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

Group Type EXPERIMENTAL

Tapered-shaped cuff tracheal tube

Intervention Type DEVICE

Tracheal intubation with a tapered-shaped cuff tube

Cylindrical-shaped cuff ETT group

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

Group Type ACTIVE_COMPARATOR

Cylindrical-shaped cuff tracheal tube

Intervention Type DEVICE

Tracheal intubation with a cylindrical-shaped cuff tube

Interventions

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Tapered-shaped cuff tracheal tube

Tracheal intubation with a tapered-shaped cuff tube

Intervention Type DEVICE

Cylindrical-shaped cuff tracheal tube

Tracheal intubation with a cylindrical-shaped cuff tube

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No