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

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

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.

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:
  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 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,
    Kazakhstan

    Active - Recruiting

  • State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center"

    Atyrau,
    Kazakhstan

    Active - Recruiting

  • State-owned public enterprise with the right of economic management "Regional Cardiology Center"

    Oral,
    Kazakhstan

    Active - Recruiting

  • State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center"

    Pavlodar,
    Kazakhstan

    Active - Recruiting

  • State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital"

    Ust-Kamenogorsk,
    Kazakhstan

    Active - Recruiting

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