Sputum RemovalNCT07056764
Development of Lung Vibration Equipment
A study testing Standard treatment and Standard treatment + Lung vibration device in people with Sputum Removal, run by Burapha University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Sputum Removal
- What is being tested?
- Standard treatment and Standard treatment + Lung vibration device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteThailand
- Study dates
- 8 Feb 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sputum Removal
- Being tested
- Standard treatment, Standard treatment + Lung vibration device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentOther
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | 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). Receives: Other: Standard treatment |
| Standard treatment + Lung vibration device | Experimental | 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). Receives: Device: Standard treatment + Lung vibration device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure will be measured in mmHg unit
Measured: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Diastolic blood pressure
Diastolic blood pressure will be measured in mmHg unit
Measured: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Body temperature
Body temperature will be measured in degree Celsius
Measured: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Oxygen saturation
Partial pressure of oxygen saturation will be measured in percent
Measured: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Sputum
Sputum will be measured for its quantity in ml unit and quality using photograph
Measured: Immediately post-intervention (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start8 Feb 2025
- Primary completion31 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sputum RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyapong Prasertsri, Burapha University
- Investigators
- Piyapong Prasertsri, Ph.D., Principal investigator, Faculty of Allied Health Sciences, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056764
- Sponsor's protocol ID
- IRB1-014/2568
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Lung Vibration Equipment
- ClinicalTrials.gov ID
- NCT07056764
- Acronym / sponsor ID
- IRB1-014/2568
- Conditions
- Sputum Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Standard treatmentPatients 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). |
| Standard treatment + Lung vibration device | Experimental | Device: Standard treatment + Lung vibration devicePatients 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatmentPatients 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. | Other | Standard treatment |
| Standard treatment + Lung vibration devicePatients 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. | Device | Standard treatment + Lung vibration device |
Primary outcome
Systolic blood pressure
Time frame: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Systolic blood pressure will be measured in mmHg unit
Diastolic blood pressure
Time frame: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Diastolic blood pressure will be measured in mmHg unit
Body temperature
Time frame: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Body temperature will be measured in degree Celsius
Oxygen saturation
Time frame: Baseline (0 minutes) and immediately post-intervention (30 minutes)
Partial pressure of oxygen saturation will be measured in percent
Sputum
Time frame: Immediately post-intervention (30 minutes)
Sputum will be measured for its quantity in ml unit and quality using photograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piyapong Prasertsri, Ph.D. principal investigator
Faculty of Allied Health Sciences, Burapha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment and Standard treatment + Lung vibration device in people with Sputum Removal, run by Burapha University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Baseline (0 minutes) and immediately post-intervention (30 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.