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

Bark Technology

Status: Enrolling

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

Treatments: Device: Vibroacoustic device BARK VibroLUNG

Study type: Observational

Funder types: Industry

Identifiers

NCT06320483

BT-01-23

Details and patient eligibility

About

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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 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 (platelets more than 50 units/l)
  5. absence of acute cerebral insufficiency (GCS more than 12 points)
  6. 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).

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 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 design

310 participants in 2 patient groups

Group with percussion massage

Group with vibroacoustic massage

Treatment:

Device: Vibroacoustic device BARK VibroLUNG