COVID-19NCT05143372
Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection
A study testing Vibrolung in people with COVID-19 and Acute Respiratory Failure, run by Astana Medical University at 3 sites in Kazakhstan.
Trial summary
Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Respiratory Failure, Vibration; Exposure
- What is being tested?
- Vibrolung
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesKazakhstan
- Study dates
- 9 Nov 2021to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- P/F less 300 torr
- COVID-19 Virus Infection
Who cannot join
- children
- acute stroke
- acute coronary syndrome
- DVT
- implanted pacemaker
- rib fracture
- infection on chest
Trial locations and contacts
3 sites in 1 country.
Kazakhstan3 sites
NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.
Astana, 010000
Multidisciplinary city hospital No. 3 of Nursultan
Astana
Multidisciplinary Infectious Diseases Hospital of Nursultan
Astana
About this study
Official title: The Effect of Various Modes of Vibroacoustic Therapy on the Course of Coronavirus Infection Complicated by Acute Respiratory Failure.
Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.
- Conditions
- COVID-19, Acute Respiratory Failure, Vibration; Exposure
- Being tested
- Vibrolung
- Keywords
- Acute Respiratory Failure, Vibration; Exposure, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrolungDevice
Vibroacoustic respiratory therapy
| Study group | Role | What they receive |
|---|---|---|
| SaO2 (oxygen status) | Active comparator | Measurment 4 times per day, ABA (acid-bases analyses) Receives: Device: Vibrolung |
| PaO2/FiO2 (respiratory index) | Active comparator | Measurment 4 times per day, ABA (acid-bases analyses) Receives: Device: Vibrolung |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time spent on ventilation
Changing of the time spent by patients on mechanical ventilation
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start9 Nov 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aidos Konkayev, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143372
- Sponsor's protocol ID
- СТЛ-000215
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Konkayev A, Bekniyazova A. Vibroacoustic therapy in the treatment of patients with COVID-19 complicated by respiratory failure: a pilot randomized controlled trial. Front Med (Lausanne). 2023 Dec 14;10:1225384. doi: 10.3389/fmed.2023.1225384. eCollection 2023.
PubMed 38155668
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Various Modes of Vibroacoustic Therapy on the Course of Coronavirus Infection Complicated by Acute Respiratory Failure.
- ClinicalTrials.gov ID
- NCT05143372
- Acronym / sponsor ID
- СТЛ-000215
- Conditions
- COVID-19, Acute Respiratory Failure, Vibration; Exposure
- Keywords
- Acute Respiratory Failure, Vibration; Exposure, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Dec 2021 (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.
Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SaO2 (oxygen status) | Active comparator | Device: VibrolungMeasurment 4 times per day, ABA (acid-bases analyses) |
| PaO2/FiO2 (respiratory index) | Active comparator | Device: VibrolungMeasurment 4 times per day, ABA (acid-bases analyses) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults
- P/F less 300 torr
- COVID-19 Virus Infection
Key exclusion criteria (7 listed)
- children
- acute stroke
- acute coronary syndrome
- DVT
- implanted pacemaker
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 |
|---|---|---|
| VibrolungVibroacoustic respiratory therapy | Device | PaO2/FiO2 (respiratory index), SaO2 (oxygen status) |
Primary outcome
Change of time spent on ventilation
Time frame: 1-2 days
Changing of the time spent by patients on mechanical ventilation
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 12 Feb 2024.
- Derived from this study: PubMed 38155668Konkayev A, Bekniyazova A. Vibroacoustic therapy in the treatment of patients with COVID-19 complicated by respiratory failure: a pilot randomized controlled trial. Front Med (Lausanne). 2023 Dec 14;10:1225384. doi: 10.3389/fmed.2023.1225384. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrolung in people with COVID-19 and Acute Respiratory Failure, run by Astana Medical University at 3 sites in Kazakhstan.
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 3 inclusion and 7 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kazakhstan. 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?
Change of time spent on ventilation (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143372, which also lists 1 linked publication.
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 12 Feb 2024.