Development of Lung Vibration Equipment

NCT07056764 | Completed DMC

• 1 other identifier: IRB1-014/2568
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sputum Removal

Outcome Measures

Primary Outcomes (5)

• Systolic blood pressure

  Systolic blood pressure will be measured in mmHg unit

  Baseline (0 minutes) and immediately post-intervention (30 minutes)

• Diastolic blood pressure

  Diastolic blood pressure will be measured in mmHg unit

  Baseline (0 minutes) and immediately post-intervention (30 minutes)

• Body temperature

  Body temperature will be measured in degree Celsius

  Baseline (0 minutes) and immediately post-intervention (30 minutes)

• Oxygen saturation

  Partial pressure of oxygen saturation will be measured in percent

  Baseline (0 minutes) and immediately post-intervention (30 minutes)

• Sputum

  Sputum will be measured for its quantity in ml unit and quality using photograph

  Immediately post-intervention (30 minutes)

Study Arms (2)

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).

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).

Device: Standard treatment + Lung vibration device

Interventions

Standard treatment 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

Standard treatment + Lung vibration device 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.

Standard treatment + Lung vibration device

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Burapha University Hospital

Mueang, Changwat Chon Buri, 20131, Thailand

Location

Study Officials

• Piyapong Prasertsri, Ph.D.

  Faculty of Allied Health Sciences, Burapha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not be employed in this crossover study, as both participants and investigators will be aware of the intervention administered in each period.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: February 8, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)