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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.

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• Intraoperative monitoring \> 2 hours or general anesthesia \> 2 hours

• Invasive arterial pressure monitoring

• Target MAP ≥ 65 mm Hg intraoperatively

• Written informed consent preoperatively

• ASA Physical Status ≤ 4

Locations
Other Locations
Greece
2nd University Department of Anesthesiology, Attikon University Hospital
RECRUITING
Athens
Contact Information
Primary
Georgia Ntalamagka, MD
geo.dalamaga@gmail.com
+306978210163
Time Frame
Start Date: 2026-03-15
Estimated Completion Date: 2027-03
Participants
Target number of participants: 100
Treatments
Experimental: HPI/AFM - Goal- Directed Hemodynamic Therapy
Participants will receive goal-directed hemodynamic therapy guided by the Hypotension Prediction Index and Assisted Fluid Management software, using the Hemosphere monitor.~Interventions include protocol-guided fluid and vasopressors to prevent or treat intraoperative hypotension.
Active_comparator: Conventional therapy
Participants will receive conventional hemodynamic intraoperative management based on anesthesiologist's clinical judgement. The Acumen IQ sensor will be placed but Hypotension Prediction Index and Assisted Fluid Management outputs will not be visible to the anesthesiologist.
Related Therapeutic Areas
Sponsors
Collaborators: Attikon Hospital
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov