Electromagnetic high-frequency chest wall oscillation to help clear sputum in people with impaired expectoration
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
This study will test whether an electromagnetic high-frequency, low‑strain chest wall oscillation device can help hospitalized adults who have difficulty clearing sputum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan, Gyeongsangnam-do) |
| Trial ID | NCT07347366 on ClinicalTrials.gov |
What this trial studies
This exploratory, interventional study tests an electromagnetic high-frequency, low-strain chest wall oscillation device in hospitalized adults judged to need sputum clearance. Participants will receive one of the device configurations (CAREWAY, a nine-motor electromagnetic system, or a single-motor electromagnetic system) during their hospital stay. Outcomes will include measures of pulmonary mucus clearance, changes in respiratory symptoms, and device safety and tolerability. Treatment sessions will be delivered in the hospital rehabilitation lab with clinician oversight and monitoring for adverse events.
Who should consider this trial
Good fit: Hospitalized adults (age ≥18) with fever or respiratory symptoms and imaging-confirmed findings for which clinicians determine sputum clearance is needed are the intended participants.
Not a fit: Patients requiring ICU-level care for severe pneumonia, those with major other pulmonary diseases (e.g., active tuberculosis or lung cancer), severe respiratory failure, unstable cardiovascular disease, unhealed head/neck surgical sites, or serious arrhythmias are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could help hospitalized patients clear sputum more effectively, potentially reducing respiratory symptoms and complications.
How similar studies have performed: Mechanical high-frequency chest wall oscillation has shown benefit for mucus clearance in conditions like cystic fibrosis and bronchiectasis, but electromagnetic low‑strain devices are newer and have limited published clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Yangsan, Gyeongsangnam-do
- Rehab lab, Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (Recruiting)
Study contacts
- Study coordinator: Jisoo Baik, Doctoral
- Email: zisoo@pusan.ac.kr
- Phone: 82+055-360-4159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.