The EU Hyprotect Registry

Edwards Lifesciences

Status: Completed

Conditions: Hemodynamic Monitoring

Treatments: Device: AcumenTM Hypotension Prediction Index software

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04972266

2021-08

Details and patient eligibility

About

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

Enrollment: 702 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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