CompletedNot Applicable

Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output

Netherlands18 participantsStarted 2019-06-24

Plain-language summary

Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.

Who can participate

Age range

18 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: * Good left and right ventricular ejection fraction * No significant valvular insufficiencies/stenoses * No significant comorbidity * Signed informed consent * Elective coronary artery bypass surgery * Postoperative mechanically ventilated admitted to the PACU Exclusion Criteria: * Withdrawal informed consent * History of pneumonectomy of lobectomy * Mechanical support of circulation * COPD Gold 3 or 4 * Complications during surgery * Postoperative bleeding \>50mL/15 minutes after admission to PACU - No thoracic drain in pleura * Postoperative pneumothorax * Participation in other research studies/trials * Elevated intra-abdominal surgery (\>12 mmHg)

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

Clinical validation of Pms-algorithm

Timeframe: Hours

Trial details

NCT IDNCT04202432

SponsorCatharina Ziekenhuis Eindhoven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-30

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