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NCT04972266 Clinical Trial

The EU Hyprotect Registry

Hemodynamic Monitoring Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04972266
Other study ID # 2021-08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 28, 2021
Est. completion date September 1, 2022

Study information
Verified date January 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 702
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• AcumenTM 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.

Locations
Country Name City State
France Hôpital Lariboisière Paris
France Les Hôpitaux Universitaires de Strasbourg Strasbourg
Germany Justus Liebig University Giessen, University Hospital of Giessen and Marburg Giessen
Germany University Medical Center Hamburg Eppendorf Hamburg
Germany Marien Hospital Herne, University Hospital Ruhr-University Bochum Herne Rhine-Westphalia
Germany University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg Marburg
Italy Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General Ancona
Italy Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona Ancona
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome
Spain Hospital Universitario Infanta Leonor, Madrid Madrid
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
United Kingdom York and Scarborough Teaching Hospitals NHS Foundation Trust Clifton York

Sponsors (2)
Lead Sponsor Collaborator
Edwards Lifesciences IPPMed - Institute for Pharmacology and Preventive Medicine

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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