We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The EU Hyprotect Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04972266
Recruitment Status : Completed
First Posted : July 22, 2021
Last Update Posted : November 2, 2022
Sponsor:
Collaborator:
IPPMed - Institute for Pharmacology and Preventive Medicine
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease Intervention/treatment
Hemodynamic Monitoring Device: AcumenTM Hypotension Prediction Index software

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 711 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry
Actual Study Start Date : September 28, 2021
Actual Primary Completion Date : September 1, 2022
Actual Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Elective major non-cardiac surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972266


Locations
Layout table for location information
France
Hôpital Lariboisière
Paris, France, 75010
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Germany
Marien Hospital Herne, University Hospital Ruhr-University Bochum
Herne, Rhine-Westphalia, Germany, 44625
Justus Liebig University Giessen, University Hospital of Giessen and Marburg
Giessen, Germany, 35392
University Medical Center Hamburg Eppendorf
Hamburg, Germany, 202246
University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg
Marburg, Germany, 35037
Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General
Ancona, Italy, 60126
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitario Infanta Leonor, Madrid
Madrid, Spain, 28031
United Kingdom
York and Scarborough Teaching Hospitals NHS Foundation Trust
Clifton, York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Edwards Lifesciences
IPPMed - Institute for Pharmacology and Preventive Medicine
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04972266    
Other Study ID Numbers: 2021-08
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases