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

Официальное название

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

Обзор

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

Вмешательства

• Устройство CAREWAY
  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.
• Устройство EM HFLS CWSE(Nine-Motor)
  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
• Устройство EM HFLS CWSE(Single-motor)
  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.

Первичные конечные точки

• BCSS, Breathlessness, Cough, and Sputum Scale [Срок оценки: Change rate in Breathlessness, Cough, and Sputum Scale (BCSS) scores at 1 week compared with baseline.]

Вторичные конечные точки (11)

• mMRC (modified Medical Research Council Dyspnea Scale) [Срок оценки: 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) [Срок оценки: Change rate in St. George's Respiratory Questionnaire (SGRQ) scores at 1 week compared with baseline.]
• Visual Analog Scale for Dyspnea (VASD) [Срок оценки: Scores at 1 week compared with baseline.]
• VAS (Visual Analogue Scale) - Cough [Срок оценки: Scores at 1 week compared with baseline.]
• Cough And Sputum Assessment Questionnaire (CASA-Q) [Срок оценки: Scores at 1 week compared with baseline.]
• Oxygen saturation (SpO2) [Срок оценки: Data at 1 week compared with baseline.]
• Forced Vital Capacity (FVC) [Срок оценки: Data at 1 week compared with baseline.]
• Forced Expiratory Volume in 1 Second (FEV1) [Срок оценки: Data at 1 week compared with baseline.]
• FEV1/FVC Ratio [Срок оценки: Data at 1 week compared with baseline.]
• Forced Expiratory Flow 25-75% (FEF 25-75) [Срок оценки: Data at 1 week compared with baseline.]
• Peak Expiratory Flow (PEF) [Срок оценки: Data at 1 week compared with baseline.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Rehab lab, Pusan National University Yangsan Hospital — Yangsan

Идентификаторы

NCT: NCT07347366 · 21-2025-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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