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OpenTrials
Completed

NCT Number: NCT04972266

The EU Hyprotect Registry

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

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Key information

Conditions

Hemodynamic Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Lariboisière, Paris, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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