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

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 Overview

• Status: Recruiting
• Conditions: Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect)
• Intervention / Treatment: Device: Vibroacoustic device BARK VibroLUNG

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Timur Karyshev; Phone Number: +77017193485; Email: sayranych@mail.ru

Study Locations

• Kazakhstan
  • Astana, Kazakhstan
    • Recruiting
    • JSC "National Research Cardiac Surgery Center"
    • Contact: Makhabbat Sansyzbaeva; Phone Number: +7(7172)703158; Email: cardiacsurgery@heartcenter.kz
    • Principal Investigator: Timur Sayranovich
  • Atyrau, Kazakhstan
    • Recruiting
    • State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center"
    • Contact: Marat Konysov; Phone Number: +7(7122)50-69-26; Email: cardiocenter@atyraumed.kz
    • Sub-Investigator: Zhangeldy Kadirov
  • Oral, Kazakhstan
    • Recruiting
    • State-owned public enterprise with the right of economic management "Regional Cardiology Center"
    • Contact: Aktilek Umirbaev; Phone Number: + 7701 338 35 04; Email: kardio-zko@mail.ru
    • Sub-Investigator: Daniyar Arenov
  • Pavlodar, Kazakhstan
    • Recruiting
    • State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center"
    • Contact: Gulzhanat Dzhakova; Phone Number: +7(7182)39-08-00; Email: info@cardiomedical.kz
    • Sub-Investigator: Inna Glowacka
  • Ust-Kamenogorsk, Kazakhstan
    • Recruiting
    • State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital"
    • Contact: Erlan Burkutov; Phone Number: +7(7232)25-60-34; Email: vko_obl@mail.ru
    • Sub-Investigator: Olesya Subbotina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group with percussion massage
Group with vibroacoustic massage	Device: Vibroacoustic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Partial pressure of oxygen (PaO2)	on days 2 and 3
Partial pressure of carbon dioxide (PaCO2)	on days 2 and 3
Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)	on days 2,3,4,5,6,7
Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2	on days 2 and 3
Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2	on days 2,3,4,5,6,7
ROX Index	on days 2 and 3
P/F index (ratio of arterial blood PO2 to oxygen fraction)	on days 2 and 3

Secondary Outcome Measures

Outcome Measure	Time Frame
pH of blood	on days 2 and 3
BE (base excess) of blood	on days 2 and 3
CBC indicators (hemoglobin)	on days 2,3,4,5,6,7 for hemoglobin
CBC indicators (hematocrit)	on days 2 and 3 for hematocrit
CBC indicators (platelets)	on days 2 and 3 for platelets
Coagulogram indicators (prothrombin time)	on days 2 and 3
Coagulogram indicators (prothrombin index)	on days 2 and 3
Coagulogram indicators (international normalized ratio)	on days 2 and 3
Coagulogram indicators (fibrinogen)	on days 2 and 3
Coagulogram indicators (activated partial thromboplastin time)	on days 2 and 3
Number of days spent in the high dependency unit (intensive care ward in the department)	through study completion, an average of 7days
Number of days in hospital	through study completion,an average of 7days
Number of days of O2 support	through study completion,an average of 7days
Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)	through study completion,an average of 7days

Collaborators and Investigators

• Sponsor: Bark Technology LLP

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Respiratory Insufficiency; Heart Septal Defects; Heart Septal Defects, Atrial; Heart Septal Defects, Ventricular
• Other Study ID Numbers: BT-01-23