RecruitingNot ApplicableNCT07301307

Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) for Perioperative Hemodynamic Optimization in Patients Under General Anesthesia

The Use of the Hypotension Prediction Index (HPI) Combined With the Assisted Fluid Management (AFM) Software for Perioperative Hemodynamic Optimization in Patients Undergoing General Anesthesia.

Sponsor

National and Kapodistrian University of Athens

Enrollment

100 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

Intraoperative hypotension

Summary

This study investigates if the Hypotension Prediction Index (HPI) combined with the Assisted Fluid Management (AFM) software can improve perioperative hemodynamic management in adult patients undergoing general anesthesia. The main question is : Does the HPI and AFM software reduce the incidence and duration of intraoperative hypotension? Does the HPI and AFM software optimize fluid and vasopressor administration? Does the HPI and AFM software improve perioperative outcomes? Participants will be randomly allocated to either an experimental group receiving goal directed hemodynamic therapy guided by HPI and AFM or a control group receiving conventional hemodynamic management.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software and Conventional Intraoperative Hemodynamic management for people with intraoperative hypotension. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAcumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software

The Acumen IQ sensor will be used with the Hemosphere monitor to guide goal-directed hemodynamic therapy. HPI predicts impending hypotension and AFM guides fluid administration. Clinicians will follow a protocol algorithm to prevent or treat intraoperative hypotension with fluids, vasopressors or inotropes.

OTHERConventional Intraoperative Hemodynamic management

Participants receive hemodynamic management based on the anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed , but HPI and AFM outputs are not visible to the clinician.

Locations(1)

2nd University Department of Anesthesiology, Attikon University Hospital

Athens, Attica, Greece

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NCT07301307

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