CompletedNot Applicable

The EU Hyprotect Registry

France, Germany, Italy702 participantsStarted 2021-09-28

Plain-language summary

European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery

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: * Consenting adult patients (≥18 years) * Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter * Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively Exclusion Criteria: * Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation * Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition) * American Society of Anesthesiology (ASA) physical status classification V or VI * Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation * Pregnancy at the time of surgery * Patients without signed informed consent / data protection statement * Patient participating in other interventional trials

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

To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software

Timeframe: Duration of the procedure through 30 days after procedure

Trial details

NCT IDNCT04972266

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Hemodynamic Monitoring trials

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.