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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with percussion massage | |||
| Group with vibroacoustic massage |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibroacoustic device BARK VibroLUNG | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pH of blood | on days 2 and 3 | |
| BE (base excess) of blood | on days 2 and 3 | |
| CBC indicators (hemoglobin) |
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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:
Relieved postoperative pain syndrome and delirium (NRS less than 5 points, BPS less than 6 points, CAM-ICU (-), RASS -3-0 points).
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timur Karyshev | Contact | +77017193485 | sayranych@mail.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JSC "National Research Cardiac Surgery Center" | Recruiting | Astana | Kazakhstan |
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| 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 |
| State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center" | Recruiting | Atyrau | Kazakhstan |
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| State-owned public enterprise with the right of economic management "Regional Cardiology Center" | Recruiting | Oral | Kazakhstan |
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| State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center" | Recruiting | Pavlodar | Kazakhstan |
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| State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital" | Recruiting | Ust-Kamenogorsk | Kazakhstan |
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