An observational study in Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), sponsored by Bark Technology LLP. Recruiting at 5 sites in Kazakhstan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Bark Technology LLP · Observational
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.
84 studies on the registry are indexed under Heart Septal Defects, Atrial; 21 are open to participants now.
This study's planned enrollment of 310 is above the median of 120 across 28 observational studies indexed under Heart Septal Defects, Atrial.
Browse Heart Septal Defects, Atrial studies →This is the only study on the registry with Bark Technology LLP as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable-severe condition of the patient according to vital signs:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Partial pressure of oxygen (PaO2)
Time frame: on days 2 and 3
Partial pressure of carbon dioxide (PaCO2)
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
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
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
pH of blood
Time frame: on days 2 and 3
BE (base excess) of blood
Time frame: on days 2 and 3
CBC indicators (hemoglobin)
Time frame: on days 2,3,4,5,6,7 for hemoglobin
CBC indicators (hematocrit)
Time frame: on days 2 and 3 for hematocrit
CBC indicators (platelets)
Time frame: on days 2 and 3 for platelets
Coagulogram indicators (prothrombin time)
Time frame: on days 2 and 3
Coagulogram indicators (prothrombin index)
Time frame: on days 2 and 3
Coagulogram indicators (international normalized ratio)
Time frame: on days 2 and 3
Coagulogram indicators (fibrinogen)
Time frame: on days 2 and 3
Coagulogram indicators (activated partial thromboplastin time)
Time frame: on days 2 and 3
Number of days spent in the high dependency unit (intensive care ward in the department)
Time frame: through study completion, an average of 7days
Number of days in hospital
Time frame: through study completion,an average of 7days
Number of days of O2 support
Time frame: through study completion,an average of 7days
Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration)
Time frame: through study completion,an average of 7days
Started Sep 2023 (actual). Primary completion is estimated for Sep 2024, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
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Heart Septal Defects, Atrial →