Respiratory Distress SyndromeNCT04435353
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
A study testing VibroLUNG in people with Respiratory Distress Syndrome and Hypoxemia, run by Astana Medical University at 2 sites in Kazakhstan.
Trial summary
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Distress Syndrome, Hypoxemia
- What is being tested?
- VibroLUNG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 22 Mar 2020to 1 Feb 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- P/F less 300 torr
- ARDS by Berlin convention
- COVID 19 bilateral pneumonia
Who cannot join
- children
- acute brain stroke
- acute coronary syndrome
- pulmonary embolism
- implanted pacemaker
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites, 2 recruiting
- Recruiting
Mukatova Irina
Astana, Astana, 010000
Irina Mukatova, MD, 8701 535 96 79, mukatovair@mail.ru
- Recruiting
Center of pulmonology Astana
Astana, 010000
Ivan Vahrushev, Dr, 8701 196 92 68
About this study
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure
Read the detailed description
This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters
- Conditions
- Respiratory Distress Syndrome, Hypoxemia
- Being tested
- VibroLUNG
- Keywords
- Vibroacustic therapy, COVID19, Pneumonia
- Medical subject headings
- Respiratory Distress Syndrome, Hypoxia, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibroLUNGDevice
Also called Vibroacustic device
Lungs intensive therapy
| Study group | Role | What they receive |
|---|---|---|
| Time-day of respiratory fail | Active comparator | Objective data Receives: Device: VibroLUNG |
| Oxygen status | Active comparator | Facultative data Receives: Device: VibroLUNG |
| Oxugen support | Active comparator | FiO2 Receives: Device: VibroLUNG |
| Adverse outcomes | Active comparator | Complication Receives: Device: VibroLUNG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery respiratory fail
Regression of respiratory failure under the influence of vibroacoustic therapy
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start22 Mar 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- Model description
- Prospective\\retrospective study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukatova Irina, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435353
- Sponsor's protocol ID
- AstanaMU
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
- ClinicalTrials.gov ID
- NCT04435353
- Acronym / sponsor ID
- AstanaMU
- Conditions
- Respiratory Distress Syndrome, Hypoxemia
- Keywords
- Vibroacustic therapy, COVID19, Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 17 Jun 2020 (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.
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure
Detailed description
This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective\retrospective study
| Arm | Type | Receives |
|---|---|---|
| Time-day of respiratory fail | Active comparator | Device: VibroLUNGObjective data |
| Oxygen status | Active comparator | Device: VibroLUNGFacultative data |
| Oxugen support | Active comparator | Device: VibroLUNGFiO2 |
| Adverse outcomes | Active comparator | Device: VibroLUNGComplication |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults
- P/F less 300 torr
- ARDS by Berlin convention
- COVID 19 bilateral pneumonia
Key exclusion criteria (5 listed)
- children
- acute brain stroke
- acute coronary syndrome
- pulmonary embolism
- 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 |
|---|---|---|
| VibroLUNGAlso: Vibroacustic deviceLungs intensive therapy | Device | Adverse outcomes, Oxugen support, Oxygen status, Time-day of respiratory fail |
Primary outcome
Recovery respiratory fail
Time frame: 5-7 days
Regression of respiratory failure under the influence of vibroacoustic therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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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.
2 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 Respiratory Distress Syndrome and Hypoxemia, run by Astana Medical University at 2 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Mukatova, PhD (8701 535 96 79, mukatovair@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery respiratory fail (time frame: 5-7 days). 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 17 Jun 2020.