Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
702 participants
OBSERVATIONAL
2021-09-28
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH
UNKNOWN
Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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Hôpital Lariboisière
Paris, , France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Marien Hospital Herne, University Hospital Ruhr-University Bochum
Herne, Rhine-Westphalia, Germany
Justus Liebig University Giessen, University Hospital of Giessen and Marburg
Giessen, , Germany
University Medical Center Hamburg Eppendorf
Hamburg, , Germany
University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg
Marburg, , Germany
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, , Italy
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Infanta Leonor, Madrid
Madrid, , Spain
York and Scarborough Teaching Hospitals NHS Foundation Trust
Clifton, York, United Kingdom
Countries
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Other Identifiers
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2021-08
Identifier Type: -
Identifier Source: org_study_id