CompletedNot Applicable

Fluid Responsiveness: SVV vs esSVV in Mechanically Ventilated and Spontaneously Breathing Patients

Russia32 participantsStarted 2021-03-20

Plain-language summary

Postoperative period after off-pump coronary artery bypass grafting (OPCAB) can be a challenging area for emerging methods for less-invasive continuous hemodynamic monitoring. The primary goal of this study is to assess the accuracy of estimated stroke volume variation (esSVV, Nihon Kohden, Japan) compared with SVV determined by conventional pulse contour analysis (SVVPCA), respectively. All the measurements and tests will be performed: 1. In mechanically ventilated patients after OPCAB within two hrs after intervention: passive leg raising (PLR), increased PEEP, and mini-fluid load (mFL) tests will be followed by standard fluid load (sFL). Monitoring: SVVPCA, PPVPCA, esSVV, HLI, PVI, pre-ejection fraction (PEP, echocardiography), CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase (PEP). 2. In spontaneously breathing patients at 18 hrs of the postoperative period: PLR, and mFL tests followed by sFL. Monitoring: SVVPCA, PPVPCA, esSVV, PVI, PEP, CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase.

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: * Elective off-pump coronary arteries bypass grafting. * Age \> 18 years and \< 80 yrs. * Preoperative echocardiographic ejection fraction \> 0.35 Exclusion Criteria: * Simultaneous operation (carotid endarterectomy, valve repair, aneurysm resection, etc.). * Significant peripheral arteriopathy. * Constant form of atrial fibrillation. * Pacemaker * Severe valve dysfunction. * The surgical requirement to harvest both radial arteries. * Intra-aortic balloon pump. * Transfer to cardiopulmonary bypass (on-pump CABG).

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

Accuracy of estimated stroke volume variation

Timeframe: immediately postoperatively

Trial details

NCT IDNCT04786652

SponsorNorthern State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-01

View on ClinicalTrials.gov More Hemodynamic Instability trials