Last updated: March 18, 2024
Sponsor: Bark Technology LLP
Overall Status: Active - Recruiting
Phase
N/A
Condition
Respiratory Failure
Lung Injury
Treatment
Vibroacoustic device BARK VibroLUNG
Clinical Study ID
NCT06320483
BT-01-23
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 trachealintubation and mechanical ventilation lasting more than 3 hours using a heart-lungmachine (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:
- 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 lessthan 6 points, CAM-ICU (-), RASS -3-0 points).
Exclusion
Exclusion Criteria:
- The presence of implanted or external medical electronic-mechanical devices in theimpact projection (pacemaker, circulatory support devices, etc.);
- Severe hypocoagulation, risk of hematoma formation or bleeding in the projection ofexposure;
- Severe hypercoagulation, risk of formation and/or migration of blood clots or embolialong 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 destructionof 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 cavafilters, 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.
Study Design
Total Participants: 310
Treatment Group(s): 1
Primary Treatment: Vibroacoustic device BARK VibroLUNG
Phase:
Study Start date:
September 20, 2023
Estimated Completion Date:
September 30, 2024
Connect with a study center
JSC "National Research Cardiac Surgery Center"
Astana,
KazakhstanActive - Recruiting
State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center"
Atyrau,
KazakhstanActive - Recruiting
State-owned public enterprise with the right of economic management "Regional Cardiology Center"
Oral,
KazakhstanActive - Recruiting
State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center"
Pavlodar,
KazakhstanActive - Recruiting
State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital"
Ust-Kamenogorsk,
KazakhstanActive - Recruiting
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