ClinicalTrials.gg
RecruitingNCT06320483Updated Mar 20, 2024

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 in Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), sponsored by Bark Technology LLP. Recruiting at 5 sites in Kazakhstan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Bark Technology LLP · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
310
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
03

In context

Heart Septal Defects, Atrial

84 studies on the registry are indexed under Heart Septal Defects, Atrial; 21 are open to participants now.

This study's planned enrollment of 310 is above the median of 120 across 28 observational studies indexed under Heart Septal Defects, Atrial.

Browse Heart Septal Defects, Atrial studies →

Lead sponsor

This is the only study on the registry with Bark Technology LLP as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age from 18 years to 80 years inclusive
  • from 18.5 to 35
  • Physical status according to 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%.
  • Stable-severe condition of the patient according to vital signs:

    1. 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)
    2. absence of acute kidney injury (urine output more than 500 ml/day)
    3. 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
    4. absence of critical coagulopathy ( more than 50 units/l)
    5. absence of acute cerebral insufficiency (GCS more than 12 points)
    6. absence of acute liver failure ( 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).

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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 ;
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
310 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group with percussion massage
  • Group with vibroacoustic massage

    Device: Vibroacoustic device BARK VibroLUNG

Interventions

  • DeviceVibroacoustic device BARK VibroLUNG

    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.

06

What researchers measure

Primary outcomes

  1. Partial pressure of oxygen (PaO2)

    Time frame: on days 2 and 3

  2. Partial pressure of carbon dioxide (PaCO2)

    Time frame: on days 2 and 3

  3. Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)

    Time frame: on days 2,3,4,5,6,7

  4. Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2

    Time frame: on days 2 and 3

  5. Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2

    Time frame: on days 2,3,4,5,6,7

  6. ROX Index

    Time frame: on days 2 and 3

  7. P/F index (ratio of arterial blood PO2 to oxygen fraction)

    Time frame: on days 2 and 3

Secondary outcomes

  1. pH of blood

    Time frame: on days 2 and 3

  2. BE (base excess) of blood

    Time frame: on days 2 and 3

  3. CBC indicators (hemoglobin)

    Time frame: on days 2,3,4,5,6,7 for hemoglobin

  4. CBC indicators (hematocrit)

    Time frame: on days 2 and 3 for hematocrit

  5. CBC indicators (platelets)

    Time frame: on days 2 and 3 for platelets

  6. Coagulogram indicators (prothrombin time)

    Time frame: on days 2 and 3

  7. Coagulogram indicators (prothrombin index)

    Time frame: on days 2 and 3

  8. Coagulogram indicators (international normalized ratio)

    Time frame: on days 2 and 3

  9. Coagulogram indicators (fibrinogen)

    Time frame: on days 2 and 3

  10. Coagulogram indicators (activated partial thromboplastin time)

    Time frame: on days 2 and 3

  11. Number of days spent in the high dependency unit (intensive care ward in the department)

    Time frame: through study completion, an average of 7days

  12. Number of days in hospital

    Time frame: through study completion,an average of 7days

  13. Number of days of O2 support

    Time frame: through study completion,an average of 7days

  14. Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)

    Time frame: through study completion,an average of 7days

07

Study locations

5 of 5 sites recruiting
  • JSC "National Research Cardiac Surgery Center"
    Astana, Kazakhstan
    Recruiting
  • State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center"
    Atyrau, Kazakhstan
    Recruiting
  • State-owned public enterprise with the right of economic management "Regional Cardiology Center"
    Oral, Kazakhstan
    Recruiting
    • Aktilek Umirbaev · Contactkardio-zko@mail.ru · + 7701 338 35 04
    • Daniyar Arenov · Sub investigator
  • State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center"
    Pavlodar, Kazakhstan
    Recruiting
    • Gulzhanat Dzhakova · Contactinfo@cardiomedical.kz · +7(7182)39-08-00
    • Inna Glowacka · Sub investigator
  • State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital"
    Ust-Kamenogorsk, Kazakhstan
    Recruiting
    • Erlan Burkutov · Contactvko_obl@mail.ru · +7(7232)25-60-34
    • Olesya Subbotina · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Sep 2024, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2023
First posted
Mar 20, 2024
StartActual
Sep 20, 2023
Primary completionEst.
Sep 2024
CompletionEst.
Sep 2024
Last update
Mar 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06320483
Lead sponsor
Bark Technology LLP
Responsible party
Sponsor
First posted
Mar 20, 2024
Start date
Sep 20, 2023
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Mar 20, 2024

Study contacts

Timur Karyshev
Contact
sayranych@mail.ru
+77017193485
View the source record on ClinicalTrials.gov ↗

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