NCT06320483RecruitingNot Applicable
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 LLP5 sites in 1 country310 target enrollmentStarted: September 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 310
- Locations
- 5
- Primary Endpoint
- Partial pressure of oxygen (PaO2)
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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 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.
Outcomes
Primary Outcomes
Partial pressure of oxygen (PaO2)
Time Frame: on days 2 and 3
Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)
Time Frame: on days 2,3,4,5,6,7
ROX Index
Time Frame: on days 2 and 3
P/F index (ratio of arterial blood PO2 to oxygen fraction)
Time Frame: on days 2 and 3
Partial pressure of carbon dioxide (PaCO2)
Time Frame: on days 2 and 3
Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2
Time Frame: on days 2 and 3
Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2
Time Frame: on days 2,3,4,5,6,7
Secondary Outcomes
- Coagulogram indicators (prothrombin index)(on days 2 and 3)
- Coagulogram indicators (fibrinogen)(on days 2 and 3)
- CBC indicators (hemoglobin)(on days 2,3,4,5,6,7 for hemoglobin)
- Coagulogram indicators (prothrombin time)(on days 2 and 3)
- Coagulogram indicators (international normalized ratio)(on days 2 and 3)
- CBC indicators (hematocrit)(on days 2 and 3 for hematocrit)
- Coagulogram indicators (activated partial thromboplastin time)(on days 2 and 3)
- Number of days in hospital(through study completion,an average of 7days)
- pH of blood(on days 2 and 3)
- BE (base excess) of blood(on days 2 and 3)
- CBC indicators (platelets)(on days 2 and 3 for platelets)
- 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 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)
Investigators
Study Sites (5)
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