MedTrace Logo

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

NCT07301307 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Intraoperative Hypotension

Interventions

DEVICE

Acumen 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.

OTHER

Conventional 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.

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Georgia Ntalamagka, MD · Attikon Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-10-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301307 on ClinicalTrials.gov