Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)NCT06320483
Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
An observational study of Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), run by Bark Technology LLP at 5 sites in Kazakhstan.
Trial summary
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
- What is being tested?
- Vibroacoustic device BARK VibroLUNG
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 5 sitesKazakhstan
- Study dates
- 20 Sep 2023to Sep 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sexes from 18 to 80 years old who are undergoing planned hospitalization for cardiac surgery (CABG, Mammary Coronary Bypass Surgery, Plastic and Replacement of Valves, Atrial Septal Defect, Ventricular Septal Defect)
Who may be able to join
- Age from 18 years to 80 years inclusive
- Body mass index from 18.5 to 35
- Physical status according to ASA II to ASA III (inclusive)
- Performed planned cardiac surgery (CS) under general anaesthesia with tracheal intubation and mechanical ventilation lasting more than 3 hours using a heart-lung machine (no more than 120 minutes)
- Left ventricular injection fraction before surgical treatment is above 40%
- Development of postoperative mixed ARF grade 1-2 (clinical criteria). SpO2 less than 95% with FiO2 21%.
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- Stable-severe condition of the patient according to vital signs:
- stable hemodynamics (norepinephrine and/or adrenaline less than 0.15 mcg/kg/min, and/or dobutamine less than 10 mcg/kg/min, and/or no need for vasopressin (ADH) for 6 hours or more)
- absence of acute kidney injury (urine output more than 500 ml/day)
- stable respiratory dynamics.P/F more than 150 units, SpO2 more than 70% with FiO2 21%.Tracheal extubation within 8 hours of completion of surgery
- absence of critical coagulopathy (platelets more than 50 units/l)
- absence of acute cerebral insufficiency (GCS more than 12 points)
- absence of acute liver failure (bilirubin less than 30 units/l)
- Relieved postoperative pain syndrome and delirium (NRS less than 5 points, BPS less than 6 points, CAM-ICU (-), RASS -3-0 points).
Who cannot join
- The presence of implanted or external medical electronic-mechanical devices in the impact projection (pacemaker, circulatory support devices, etc.);
- Severe hypocoagulation, risk of hematoma formation or bleeding in the projection of exposure;
- Severe hypercoagulation, risk of formation and/or migration of blood clots or emboli along the great vessels in the projection of exposure;
- Acute cerebrovascular accident (ACB), first 1-3 days;
- Cerebral Edema;
- High intracranial pressure;
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- The presence of many purulent or burn wound surfaces in the projection of exposure;
- Presence of an unstable rib fracture;
- Pneumohemomediastinum and/or subcutaneous emphysema of the chest;
- Risk of development of hemo-pneumothorax;
- Osteomyelitis of the ribs and/or thoracic spine;
- Spinal fracture without orthopedic fixation;
- Trauma to the chest or abdomen with bleeding;
- High risk of seizures (CNS pathologies);
- The presence of an oncological process in the projection of exposure with destruction of tumor tissue and the risk of bleeding and/or metastasis;
- The presence of endothoracic and/or large endovascular implants (aortic stents, intra-aortic balloon pumps, endocardial catheters, mechanical heart valves, vena cava filters, subcutaneous venous ports, permanent hemodialysis devices);
- Heart rhythm disturbances (ventricular fibrillation, ventricular tachycardia);
- Hypovolemia;
- Disturbances of water-electrolyte balance and acid-base balance;
- Meningoencephalitis;
- Destructive purulent pneumonia;
- High risk of pulmonary hemorrhage;
- Hiatal hernia;
- Risk of dislocation of implanted drainage tubes and catheters;
- The presence of multiple wound surfaces in the projection of exposure;
- Severe bullous deformation of the lungs;
- Severe kyphoscoliosis;
- Spontaneous pneumothorax within the last year;
- Estimated systolic pressure over the pulmonary artery more than 50 mm Hg. Art.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Kazakhstan5 sites, 5 recruiting
- Recruiting
JSC "National Research Cardiac Surgery Center"
Astana
Makhabbat Sansyzbaeva, +7(7172)703158, cardiacsurgery@heartcenter.kz
Timur Sayranovich
- Recruiting
State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center"
Atyrau
Marat Konysov, +7(7122)50-69-26, cardiocenter@atyraumed.kz
Zhangeldy Kadirov
- Recruiting
State-owned public enterprise with the right of economic management "Regional Cardiology Center"
Oral
Aktilek Umirbaev, + 7701 338 35 04, kardio-zko@mail.ru
Daniyar Arenov
- Recruiting
State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center"
Pavlodar
Gulzhanat Dzhakova, +7(7182)39-08-00, info@cardiomedical.kz
Inna Glowacka
- Recruiting
State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital"
Ust-Kamenogorsk
Erlan Burkutov, +7(7232)25-60-34, vko_obl@mail.ru
Olesya Subbotina
About this study
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period.
- Being tested
- Vibroacoustic device BARK VibroLUNG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibroacoustic device BARK VibroLUNGDevice
The BARK VibroLUNG vibroacoustic device is intended for the treatment and prevention of respiratory pathologies.
The BARK VibroLUNG vibroacoustic device with accessories is a medical device and is intended for the treatment of pathological conditions associated with obstructive and restrictive lung diseases in patients in medical institutions.
Field of application: physiotherapy of the chest organs, treatment and prevention of respiratory failure.
The therapeutic mechanism of action is due to three main effects: improved bronchial drainage, improved ventilation-perfusion ratios, and the "lung opening" maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Group with percussion massage | Not described | |
| Group with vibroacoustic massage | Not described Receives: Device: Vibroacoustic device BARK VibroLUNG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial pressure of oxygen (PaO2)
Measured: on days 2 and 3
Partial pressure of carbon dioxide (PaCO2)
Measured: on days 2 and 3
Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)
Measured: on days 2,3,4,5,6,7
Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2
Measured: on days 2 and 3
Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2
Measured: on days 2,3,4,5,6,7
ROX Index
Measured: on days 2 and 3
P/F index (ratio of arterial blood PO2 to oxygen fraction)
Measured: on days 2 and 3
Secondary outcomes (14)
pH of blood
Measured: on days 2 and 3
BE (base excess) of blood
Measured: on days 2 and 3
CBC indicators (hemoglobin)
Measured: on days 2,3,4,5,6,7 for hemoglobin
CBC indicators (hematocrit)
Measured: on days 2 and 3 for hematocrit
CBC indicators (platelets)
Measured: on days 2 and 3 for platelets
Coagulogram indicators (prothrombin time)
Measured: on days 2 and 3
Coagulogram indicators (prothrombin index)
Measured: on days 2 and 3
Coagulogram indicators (international normalized ratio)
Measured: on days 2 and 3
Coagulogram indicators (fibrinogen)
Measured: on days 2 and 3
Coagulogram indicators (activated partial thromboplastin time)
Measured: on days 2 and 3
Number of days spent in the high dependency unit (intensive care ward in the department)
Measured: through study completion, an average of 7days
Number of days in hospital
Measured: through study completion,an average of 7days
Number of days of O2 support
Measured: through study completion,an average of 7days
Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)
Measured: through study completion,an average of 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bark Technology LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320483
- Sponsor's protocol ID
- BT-01-23
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT06320483
- Acronym / sponsor ID
- BT-01-23
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Bark Technology LLPIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 20 Mar 2024 (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.
The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with percussion massage | – | – |
| Group with vibroacoustic massage | – | Device: Vibroacoustic device BARK VibroLUNG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes from 18 to 80 years old who are undergoing planned hospitalization for cardiac surgery (CABG, Mammary Coronary Bypass Surgery, Plastic and Replacement of Valves, Atrial Septal Defect, Ventricular Septal Defect)
Key inclusion criteria (14 listed)
- Age from 18 years to 80 years inclusive
- Body mass index from 18.5 to 35
- Physical status according to ASA II to ASA III (inclusive)
- Performed planned cardiac surgery (CS) under general anaesthesia with tracheal intubation and mechanical ventilation lasting more than 3 hours using a heart-lung machine (no more than 120 minutes)
- Left ventricular injection fraction before surgical treatment is above 40%
Key exclusion criteria (29 listed)
- The presence of implanted or external medical electronic-mechanical devices in the impact projection (pacemaker, circulatory support devices, etc.);
- Severe hypocoagulation, risk of hematoma formation or bleeding in the projection of exposure;
- Severe hypercoagulation, risk of formation and/or migration of blood clots or emboli along the great vessels in the projection of exposure;
- Acute cerebrovascular accident (ACB), first 1-3 days;
- Cerebral Edema;
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 |
|---|---|---|
| Vibroacoustic device BARK VibroLUNGThe BARK VibroLUNG vibroacoustic device is intended for the treatment and prevention of respiratory pathologies. The BARK VibroLUNG vibroacoustic device with accessories is a medical device and is intended for the treatment of pathological conditions associated with obstructive and restrictive lung diseases in patients in medical institutions. Field of application: physiotherapy of the chest organs, treatment and prevention of respiratory failure. The therapeutic mechanism of action is due to three main effects: improved bronchial drainage, improved ventilation-perfusion ratios, and the "lung opening" maneuver. | Device | Group with vibroacoustic massage |
Primary outcome
Partial pressure of oxygen (PaO2)
Time frame: on days 2 and 3
Partial pressure of carbon dioxide (PaCO2)
Time frame: on days 2 and 3
Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)
Time frame: on days 2,3,4,5,6,7
Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2
Time frame: on days 2 and 3
Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2
Time frame: on days 2,3,4,5,6,7
ROX Index
Time frame: on days 2 and 3
P/F index (ratio of arterial blood PO2 to oxygen fraction)
Time frame: on days 2 and 3
14 secondary outcomes
pH of blood
Time frame: on days 2 and 3
BE (base excess) of blood
Time frame: on days 2 and 3
CBC indicators (hemoglobin)
Time frame: on days 2,3,4,5,6,7 for hemoglobin
CBC indicators (hematocrit)
Time frame: on days 2 and 3 for hematocrit
CBC indicators (platelets)
Time frame: on days 2 and 3 for platelets
Coagulogram indicators (prothrombin time)
Time frame: on days 2 and 3
Coagulogram indicators (prothrombin index)
Time frame: on days 2 and 3
Coagulogram indicators (international normalized ratio)
Time frame: on days 2 and 3
Coagulogram indicators (fibrinogen)
Time frame: on days 2 and 3
Coagulogram indicators (activated partial thromboplastin time)
Time frame: on days 2 and 3
Number of days spent in the high dependency unit (intensive care ward in the department)
Time frame: through study completion, an average of 7days
Number of days in hospital
Time frame: through study completion,an average of 7days
Number of days of O2 support
Time frame: through study completion,an average of 7days
Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)
Time frame: through study completion,an average of 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), run by Bark Technology LLP 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 14 inclusion and 29 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 20 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timur Karyshev (+77017193485, sayranych@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial pressure of oxygen (PaO2) (time frame: on days 2 and 3). The study lists 7 primary outcomes in all. 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 20 Mar 2024.