Electromagnetic High-Frequency Chest Wall Oscillation on Pulmonary Mucus Clearance in Patients With Impaired Self-Expectoration

Pusan National University Yangsan Hospital45 enrolled

Overview

This exploratory study aims to evaluate the efficacy and safety of an electromagnetic high-frequency, low-strain chest wall oscillation device for enhancing pulm

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sputum

Interventions

CAREWAYDEVICE

CAREWAY , 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)DEVICE

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

EM HFLS CWSE(Single-motor)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Rehab lab, Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.

Secondary Outcomes

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.

Time frame: 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)

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.

Time frame: Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.

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

Central Contacts

Jisoo Baik, Doctoral

CONTACT

82+055-360-4159 zisoo@pusan.ac.kr

Data from ClinicalTrials.gov

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