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Development of Lung Vibration Equipment

Development of Lung Vibration Equipment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07056764
Enrollment
25
Registered
2025-07-09
Start date
2025-02-08
Completion date
2025-11-30
Last updated
2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sputum Removal

Brief summary

This study designed a portable and easily accessible lung vibration device that is simple to use and can operate with both a battery system and a charging system for greater convenience. It helps enhance the effectiveness of mucus drainage, prevents complications, and reduces both the duration and cost of hospital treatment.

Detailed description

Lung vibration device uses a motor as the power source to generate vibrations and has a shape similar to an iron. It is connected by an electrical cord in this section and can operate using either a battery system or a charging system. It features a vertically aligned handle perpendicular to the main body for a firm grip. The base of the device has a sponge head to absorb shock from the vibration during use, which is removable. The on/off switch is located at the end of the handle. This device uses 220-volt alternating current. The unit weighs approximately 1.1 kilograms and is made of strong and durable plastic.

Interventions

OTHERStandard treatment

Patients will be randomly assigned by drawing lots to determine the initial type of lung vibration treatment they will receive: either standard treatment alone or standard treatment combined with the lung vibration device.

DEVICEStandard treatment + Lung vibration device

Patients will be randomly assigned by drawing lots to determine the initial type of lung vibration treatment they will receive: either standard treatment alone or standard treatment combined with the lung vibration device.

Sponsors

Burapha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

Masking will not be employed in this crossover study, as both participants and investigators will be aware of the intervention administered in each period.

Intervention model description

Patients who consent to participate in the study and pass the screening process will be randomly assigned by drawing lots to determine which type of lung vibration they will receive first. For all patients, lung vibration will be performed in conjunction with chest percussion and suctioning. Each volunteer will participate in the study for two days, receiving different treatments each day according to the randomly assigned order.

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* Male or female * Aged 18-59 years * Inpatients at Burapha University Hospital, Mueang District, Chonburi Province, with pulmonary secretion retention * Referred by their attending physician for enhanced secretion clearance through physical therapy methods

Exclusion criteria

* Having inflamed wounds on the chest or back * Having unstable vital signs, defined as: resting heart rate \<60 or \>100 beats per minute; blood pressure \<90/60 or \>120/80 mmHg; respiratory rate \<12 or \>20 breaths per minute; oxygen saturation \<95%; and body temperature \>37°C * Having a bleeding tendency, defined as a platelet count \<20,000 per cubic millimeter * Taking medications that increase bleeding risk within 7 days prior to participation, including: Anticoagulants (such as Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban), Antiplatelet agents (such as Aspirin, Clopidogrel, Dipyridamole, Prasugrel, Ticagrelor) * Having an International Normalized Ratio (INR) \>1.1 for those not on anticoagulants, and \>3.0 for those on anticoagulants * Having subcutaneous emphysema * Experiencing severe hemoptysis (coughing up blood) * Having chest wall pain * Having acute spinal cord injury, rib fractures, or conditions associated with high fracture risk * Having skin grafts or burn wounds * Being admitted to intensive care units (ICU, RICU, or CICU) * Having untreated pneumothorax * Having an acute inflammatory process of the respiratory system * Having inflammatory or infectious conditions such as tuberculosis, lung abscess, or COVID-19 * Having respiratory diseases that are contraindications or precautions for lung vibration, including COPD, uncomplicated pneumonia, asthma, lung cancer, or metastatic cancer

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressureBaseline (0 minutes) and immediately post-intervention (30 minutes)Systolic blood pressure will be measured in mmHg unit
Diastolic blood pressureBaseline (0 minutes) and immediately post-intervention (30 minutes)Diastolic blood pressure will be measured in mmHg unit
Body temperatureBaseline (0 minutes) and immediately post-intervention (30 minutes)Body temperature will be measured in degree Celsius
Oxygen saturationBaseline (0 minutes) and immediately post-intervention (30 minutes)Partial pressure of oxygen saturation will be measured in percent
SputumImmediately post-intervention (30 minutes)Sputum will be measured for its quantity in ml unit and quality using photograph

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026