Electromagnetic high-frequency chest wall oscillation to help clear sputum in people with impaired expectoration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.