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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- BCSS, Breathlessness, Cough, and Sputum Scale
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: 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
Intervention: 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.
Intervention: EM HFLS CWSE(Single-motor) (Device)
Outcomes
Primary Outcomes
BCSS, Breathlessness, Cough, and Sputum Scale
Time Frame: 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.
Secondary Outcomes
- 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.)
Investigators
Yong-il Shin
Professor
Pusan National University Yangsan Hospital