- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517497
The Course of Acute Respiratory Failure in Geriatric Patients With Hip Fracture Using Different Modes of a Vibroacoustic Device for the Lungs
A medical professional trained in the procedure and use of the device will conduct the vibroacoustic therapy session. He will also take blood samples.
In the control group, patients will undergo vibroacoustic pulmonary therapy in the "Pneumonia" mode, and in the control group, in the "Prevention" mode. Vibroacoustic pulmonary therapy will be conducted over a period of 5 days. A similar algorithm of actions is planned for both groups. VALT sessions will be conducted 4-6 times a day for 5 minutes in combination with treatment according to the protocol for the use of "Vibroacoustic Therapy" of the lungs of the Ministry of Health of the Republic of Kazakhstan. The device's emitters will be applied to the affected areas of the lungs. Since the device has long cords for the emitters and is portable, it is not difficult to change the patient's position and does not require their active participation, which is important for patients on ventilators and with limited mobility.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Assema Bekniyazova
- Phone Number: 87752305441
- Email: asemabek9@gmail.com
Study Locations
-
-
-
Astana, Kazakhstan, 010000
- Recruiting
- Astana Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- respiratory failure;
- hip fracture;
- Injury Severity Score no higher than 8 points.
Exclusion Criteria:
- All contraindications for use of the device:
- terminal condition of the patient;
- shock;
- paradoxical pathological breathing;
- hypertensive crisis;
- severe hypocoagulation with a risk of hematoma formation or bleeding in the projection of exposure;
- severe hypercoagulation, risk of thrombus/embolus migration along the main vessels in the area of exposure;
- acute cerebrovascular accident in the first 1-3 days;
- brain edema;
- presence of multiple purulent or burn wound surfaces in the area of exposure;
- presence of unstable rib fractures;
- pneumomediastinum and/or subcutaneous emphysema of the chest;
- osteomyelitis of the ribs and/or thoracic spine;
- spinal fracture without orthopedic fixation;
- chest or abdominal trauma with bleeding;
- Injury Severity Score greater than 8 points;
- concomitant diseases in the stage of decompensation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: patients will undergo Vibrolung in the "Pneumonia" mode.
vibroacoustic physiotherapy
|
BARK VibroLUNG vibroacoustic device (No.
RK-MT-7No.013611
dated October 7, 2014).
The device is designed for the treatment and prevention of respiratory diseases.
The device operates on the principle of exposure to a powerful vibroacoustic signal generated by special emitters.
During the procedure, the emitters are pressed against the surface of the chest, and the procedure lasts an average of 5 minutes.
The frequency of the signal constantly changes and has complex modulation, which ensures maximum effectiveness.
Depending on the selected program, the signal can cause the effect of percussion, soft vibration, smooth alternation of acoustic signal and vibration, or combinations thereof.
|
|
Other: patients will undergo vibroacoustic pulmonary therapy in the "Prevention" mode.
vibroacoustic physiotherapy
|
BARK VibroLUNG vibroacoustic device (No.
RK-MT-7No.013611
dated October 7, 2014).
The device is designed for the treatment and prevention of respiratory diseases.
The device operates on the principle of exposure to a powerful vibroacoustic signal generated by special emitters.
During the procedure, the emitters are pressed against the surface of the chest, and the procedure lasts an average of 5 minutes.
The frequency of the signal constantly changes and has complex modulation, which ensures maximum effectiveness.
Depending on the selected program, the signal can cause the effect of percussion, soft vibration, smooth alternation of acoustic signal and vibration, or combinations thereof.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial blood gases
Time Frame: Day 1
|
On day 1 of vibroacoustic therapy, arterial blood sampling will be performed to determine PaO2 (mmHg), PaC02 (mmHg), as well as for dynamics during transfer to the specialized department.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest X-ray
Time Frame: Day 1
|
Chest X-ray at admission and after vibroacoustic therapy sessions at least twice in total, with technical capabilities(The X-ray image)
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AP25795127
- Grant No.AP25795127 (Other Grant/Funding Number: This research has been/was/is funded by the Science Committee of the Ministry of Education and Science of the Republic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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