UnknownNot 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

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 range

18 Years – 80 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 80 Years

Sex

ALL

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