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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

Kazakhstan310 participantsStarted 2023-09-20

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

What they're measuring

Partial pressure of oxygen (PaO2)

Timeframe: on days 2 and 3

Partial pressure of carbon dioxide (PaCO2)

Timeframe: on days 2 and 3

Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)

Timeframe: on days 2,3,4,5,6,7

Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2

Timeframe: on days 2 and 3

Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2

Timeframe: on days 2,3,4,5,6,7

ROX Index

Timeframe: on days 2 and 3

P/F index (ratio of arterial blood PO2 to oxygen fraction)

Timeframe: on days 2 and 3

Trial details

NCT IDNCT06320483

SponsorBark Technology LLP

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09

Contact for this trial

Timur Karyshev

+77017193485 sayranych@mail.ru

View on ClinicalTrials.gov More Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

What they're measuring

Partial pressure of oxygen (PaO2)

Timeframe: on days 2 and 3

Partial pressure of carbon dioxide (PaCO2)

Timeframe: on days 2 and 3

Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation)

Timeframe: on days 2,3,4,5,6,7

Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2

Timeframe: on days 2 and 3

Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2

Timeframe: on days 2,3,4,5,6,7

ROX Index

Timeframe: on days 2 and 3

P/F index (ratio of arterial blood PO2 to oxygen fraction)

Timeframe: on days 2 and 3