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

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Sputum

Treatments: Device: EM HFLS CWSE(Single-motor); Device: CAREWAY; Device: EM HFLS CWSE(Nine-Motor)

Study type: Interventional

Funder types: Other

Identifiers

NCT07347366

21-2025-005

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Device: CAREWAY

Nine-Motor Device Group

Experimental group

Description:

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

Treatment:

Device: EM HFLS CWSE(Nine-Motor)

Single-Motor Device Intervention

Experimental group

Description:

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.

Treatment:

Device: EM HFLS CWSE(Single-motor)