Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients

Tri-Service General Hospital176 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

176

Conditions

Breast Cancer Postoperative Sore Throat Subglottic Airway Injury Endotracheal Tube Cuff

Interventions

Tapered-shaped cuff tracheal tubeDEVICE

Tracheal intubation with a tapered-shaped cuff tube

Cylindrical-shaped cuff tracheal tubeDEVICE

Tracheal intubation with a cylindrical-shaped cuff tube

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tri-Service General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

The incidence of postoperative sore throat

Time frame: Postoperative 48 hours

The severity of postoperative sore throat

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)

Time frame: Postoperative 48 hours

Secondary Outcomes

Intraoperative fentanyl consumption

Time frame: The end of surgery

Intraoperative propofol consumption

Time frame: The end of surgery

Intraoperative rocuronium consumption

Time frame: The end of surgery

The degree of subglottic injury

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)

Time frame: Intraoperative (The time point at extubation)

Data from ClinicalTrials.gov

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