The EU Hyprotect Registry

European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04972266

Enrollment

702

Registered

2021-07-22

Start date

2021-09-28

Completion date

2022-09-01

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Monitoring

Keywords

Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring

Brief summary

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

Interventions

DEVICEAcumenTM Hypotension Prediction Index software

The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software	Duration of the procedure through 30 days after procedure	To describe the time-weighted average (TWA) mean arterial pressure (MAP) \<65 mmHg when using AcumenTM Hypotension Prediction Index software

Countries

France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026