The EU Hyprotect Registry

NCT04972266 | Completed FDA Device

• 1 other identifier: 2021-08
• Study Type: observational
• Target: 702
• Locations: 5 countries
• Sites: 12

Brief Summary

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

Conditions

Hemodynamic Monitoring

Keywords

Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

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

  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

Interventions

AcumenTM Hypotension Prediction Index software DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective major non-cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead
• IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH: collaborator

Study Sites (12)

Hôpital Lariboisière

Paris, 75010, France

Location

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Marien Hospital Herne, University Hospital Ruhr-University Bochum

Herne, Rhine-Westphalia, 44625, Germany

Location

Justus Liebig University Giessen, University Hospital of Giessen and Marburg

Giessen, 35392, Germany

Location

University Medical Center Hamburg Eppendorf

Hamburg, 202246, Germany

Location

University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg

Marburg, 35037, Germany

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General

Ancona, 60126, Italy

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Infanta Leonor, Madrid

Madrid, 28031, Spain

Location

York and Scarborough Teaching Hospitals NHS Foundation Trust

Clifton, York, YO31 8HE, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: September 28, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 4, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); ES (2); IT (3); DE (4); GB (1)