Effects of Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration: An Investigator-Initiated, Single-Center, Prospective, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- BCSS, Breathlessness, Cough, and Sputum Scale
研究概览
简要总结
This exploratory study aims to evaluate the efficacy and safety of an electromagnetic high-frequency, low-strain chest wall oscillation device for enhancing pulm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients who require sputum clearance.
- •Patients who present with fever or respiratory symptoms (cough, sputum) and, after confirmation of findings on imaging studies, are judged by the clinician to require sputum clearance.
- •Adult patients (≥ 18 years) who have signed the informed consent form, or patients for whom consent has been obtained from a legally authorized representative
排除标准
- •Patients with severe pneumonia requiring intensive care unit (ICU) treatment.
- •Patients with major pulmonary diseases other than pneumonia, such as active tuberculosis or lung cancer.
- •Patients with severe respiratory failure (PaO₂/FiO₂ ≤ 200 mmHg).
- •Patients with hemodynamically unstable cardiovascular disease (myocardial infarction within the past 3 months, or heart failure of NYHA class 3 or higher).
- •Patients hospitalized for head and neck trauma whose surgical site has not yet healed.
- •Patients with serious cardiac arrhythmias or hemodynamic instability.
- •Patients who have had pneumothorax or massive hemoptysis within the past 6 months, or who currently have hemoptysis.
- •Patients who have undergone spinal surgery within the past 6 months or who have acute spinal injury.
- •Patients with osteoporosis.
- •Patients with bronchopleural fistula.
- •Pregnant or breastfeeding women.
- •Patients diagnosed with cervical disc disease.
- •Individuals who have participated in clinical studies two or more times in the same year, or who have participated in another clinical study within the past 6 months (however, patients enrolled in chronic lung disease cohort studies such as asthma or COPD are allowed).
- •Individuals who, in the judgment of the principal investigator or sub-investigator, have clinically significant findings that make them unsuitable for participation in this study
研究组 & 干预措施
Control Group
A high-frequency chest wall oscillation device in the form of a vest (Todaki) is used in patients who require clearance of mucus retained in the lungs, providing high-frequency chest wall vibrations to dislodge sputum adherent to the bronchial walls and facilitate removal of secretions.
干预措施: CAREWAY (Device)
Nine-Motor Device Group
Description:This bed-type medical device delivers vibrational energy across the chest wall for patients with respiratory conditions. aiding in the clearance of accumulated sputum in the airways and lungs. It incorporates nine electromagnetic high-frequency, low-strain vibration motors to produce distributed vibrational energy, which is applied via the chest wall oscillation plate to multiple lung regions, enhancing comprehensive sputum clearance through multi-point oscillation
干预措施: EM HFLS CWSE(Nine-Motor) (Device)
Single-Motor Device Intervention
Description: This bed-type medical device applies vibrational energy to the chest wall of patients with respiratory diseases to facilitate sputum clearance from the airways and lungs. The device employs a single electromagnetic high-frequency, low-strain vibration motor that generates vibrational energy, which transmits through the chest wall oscillation plate directly to the patient's chest, promoting effective mucus mobilization via targeted oscillations.
干预措施: EM HFLS CWSE(Single-motor) (Device)
结局指标
主要结局
BCSS, Breathlessness, Cough, and Sputum Scale
时间窗: Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.
The Breathlessness, Cough, and Sputum Scale (BCSS) is a patient-reported outcome measure assessing the severity of breathlessness, cough, and sputum. Each symptom is rated by the patient on a numeric scale from 0 (no symptoms) to 4 (severe symptoms). Individual symptom scores and the total score, calculated as the sum of the three items (range 0-12), are used for analysis, with higher scores indicating more severe symptoms.
次要结局
- mMRC (modified Medical Research Council Dyspnea Scale)(Change rate in modified Medical Research Council (mMRC) dyspnea scores at 1 week compared with baseline for patient symptom assessment.)
- St. George's Respiratory Questionnaire (SGRQ)(Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.)
- Visual Analog Scale for Dyspnea (VASD)(Scores at 1 week compared with baseline.)
- VAS (Visual Analogue Scale) - Cough(Scores at 1 week compared with baseline.)
- Cough And Sputum Assessment Questionnaire (CASA-Q)(Scores at 1 week compared with baseline.)
- Oxygen saturation (SpO2)(Data at 1 week compared with baseline.)
- Forced Vital Capacity (FVC)(Data at 1 week compared with baseline.)
- Forced Expiratory Volume in 1 Second (FEV1)(Data at 1 week compared with baseline.)
- FEV1/FVC Ratio(Data at 1 week compared with baseline.)
- Forced Expiratory Flow 25-75% (FEF 25-75)(Data at 1 week compared with baseline.)
- Peak Expiratory Flow (PEF)(Data at 1 week compared with baseline.)
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital