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Development of Lung Vibration Equipment

NCT ID: NCT07056764

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-08

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Sputum Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Standard treatment

Patients who draw the standard lung vibration will receive manual chest vibration performed by a physical therapist for 1-2 minutes per time, continuously for at least 6 times per set, with a total duration not exceeding 30 minutes. On the following day, they will switch to the other procedure: lung vibration using the vibration device developed by the researcher, for 1-2 minutes per time, continuously for at least 6 times per set, with a total duration not exceeding 30 minutes as well (in conjunction with chest percussion and suctioning).

Group Type ACTIVE_COMPARATOR

Standard treatment

Intervention Type OTHER

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.

Standard treatment + Lung vibration device

Patients who draw the lung vibration using the vibration device will receive the procedure using the device developed by the researcher, for 1-2 minutes per time, continuously for at least 6 times per set, with a total duration not exceeding 30 minutes. On the following day, they will switch to the other procedure: standard manual lung vibration performed by a physical therapist, for 1-2 minutes per time, continuously for at least 6 times per set, with a total duration not exceeding 30 minutes as well (in conjunction with chest percussion and suctioning).

Group Type EXPERIMENTAL

Standard treatment + Lung vibration device

Intervention Type 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.

Interventions

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Standard 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.

Intervention Type OTHER

Standard 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Burapha University

OTHER

Sponsor Role lead

Responsible Party

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Piyapong Prasertsri

Associate Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piyapong Prasertsri, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Allied Health Sciences, Burapha University

Locations

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Burapha University Hospital

Mueang, Changwat Chon Buri, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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IRB1-014/2568

Identifier Type: -

Identifier Source: org_study_id