This exploratory study aims to evaluate the efficacy and safety of an electromagnetic high-frequency, low-strain chest wall oscillation device for enhancing pulm
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
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).
Parallel
CAREWAY
DeviceCAREWAY , 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.
EM HFLS CWSE(Nine-Motor)
DeviceThis 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
EM HFLS CWSE(Single-motor)
DeviceThis 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.
BCSS, Breathlessness, Cough, and Sputum Scale
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.
mMRC (modified Medical Research Council Dyspnea Scale)
The modified Medical Research Council (mMRC) Dyspnea Scale is a patient-reported measure assessing the degree of breathlessness during daily activities. Dyspnea severity is rated on a 5-point ordinal scale ranging from 0 (breathlessness only with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing or undressing). Higher scores indicate more severe dyspnea.
St. George's Respiratory Questionnaire (SGRQ)
The St. George's Respiratory Questionnaire (SGRQ) is a validated patient-reported outcome measure assessing health-related quality of life in patients with respiratory disease. It consists of three domains: Symptoms, Activity, and Impacts. Domain scores and the total score range from 0 to 100, with higher scores indicating worse health status and greater impairment of respiratory-related quality of life.
Visual Analog Scale for Dyspnea (VASD)
It is a subjective assessment scale in which patients rate their perceived "difficulty in breathing" from 0 (none) to 10 (worst), and it is used to objectively assess changes in symptoms and evaluate treatment effects in patients with respiratory or cardiac diseases
VAS (Visual Analogue Scale) - Cough
The severity of cough (VAS) is assessed using a Visual Analogue Scale, a subjective method in which patients rate the severity of their cough by marking their symptoms on a straight line from 0 (no cough at all) to 10 (the worst imaginable), which is then recorded as a score.
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