Respiratory FailureNCT03911947
Evaluation of the Effectiveness of Vibroacoustic Therapy in the Complex Treatment of Acute Respiratory Failure
A study testing Vibrolung in people with Respiratory Failure, run by Astana Medical University at 5 sites in Kazakhstan.
Trial summary
Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Vibrolung
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 5 sitesKazakhstan
- Study dates
- 2 May 2019to 31 Jul 2020
- 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
- ARDS by Berlin convention
Who cannot join
- children
- acute stroke
- acute coronary syndrome
- DVT
- implanted pacemaker
- rib fracture
- infection on chest
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Kazakhstan5 sites
City clinical hospital №7
Almaty, 050000
City clinical hospital №1
Astana, 010000
National Cardiac Surgery Center
Astana, 010000
Scientific Research Institute of Traumatology and Orthopedics
Astana, 010000
Regional cardiology center
Shymkent, 160000
About this study
Official title: Assessing the Ventilatory Parameters in Patients With Acute Respiratory Failure After Vibroacoustic Pulmonary Therapy.
Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure
Read the detailed description
Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.
- Conditions
- Respiratory Failure
- Being tested
- Vibrolung
- Keywords
- Vibroacoustic therapy, acute respiratory failure, pneumonia
- Medical subject headings
- Respiratory Insufficiency, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrolungDevice
Device for 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 |
| AB (actual bicarbonat level) | 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 posted11 Apr 2019
- Study start2 May 2019
- Primary completion30 Apr 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy
- Masking
- None (open label)
- Enrolment
- 113 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
- NCT03911947
- Sponsor's protocol ID
- 1972
- Status last verified
- Jan 2021
- First submitted
- 8 Apr 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Ventilatory Parameters in Patients With Acute Respiratory Failure After Vibroacoustic Pulmonary Therapy.
- ClinicalTrials.gov ID
- NCT03911947
- Acronym / sponsor ID
- 1972
- Conditions
- Respiratory Failure
- Keywords
- Vibroacoustic therapy, acute respiratory failure, pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Apr 2019 (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.
Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure
Detailed description
Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy
| 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) |
| AB (actual bicarbonat level) | 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
- ARDS by Berlin convention
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 |
|---|---|---|
| VibrolungDevice for vibroacoustic respiratory therapy | Device | AB (actual bicarbonat level), 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 14 Jan 2021.
- Individual participant dataSharing planned: No
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Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
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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.
5 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 Failure, run by Astana Medical University at 5 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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 14 Jan 2021.