Using HPI and AFM to prevent low blood pressure during 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.

This trial will test whether the Hypotension Prediction Index together with Assisted Fluid Management can reduce how often and how long adults experience low blood pressure during surgery under general anesthesia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (Academic / other)
• Locations: 1 site (Athens, Attica)
• Trial ID: NCT07301307 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized trial enrolling 100 adults undergoing elective surgery with invasive arterial monitoring to compare goal-directed hemodynamic therapy guided by HPI and AFM versus conventional management. The HPI software predicts impending hypotension from the arterial waveform, giving clinicians early warning, while the AFM algorithm advises crystalloid administration only when it is expected to raise stroke volume. Primary outcomes include incidence and duration of intraoperative hypotension, with secondary outcomes addressing fluid and vasopressor use and perioperative organ-related complications. Participants must have general anesthesia expected to last at least two hours and a target MAP of ≥65 mmHg.

Who should consider this trial

Good fit: Adults having elective surgery under general anesthesia with planned invasive arterial pressure monitoring for at least two hours, a target MAP ≥65 mmHg, and ASA physical status ≤4 are ideal candidates.

Not a fit: Patients having emergency surgery, those with a target MAP other than 65 mmHg, severe preoperative hypotension, or severe heart failure (e.g., LVEF <20%) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce intraoperative hypotension and related postoperative organ complications by enabling earlier, more targeted fluid and vasopressor therapy.

How similar studies have performed: Prior studies of HPI and of goal-directed hemodynamic therapy have reported reductions in hypotension and improved hemodynamic targets, but evidence specifically combining HPI with AFM guidance is still limited.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Target MAP other than 65 mm Hg
* Severe preoperative hypotension (MAP \< 65 mm Hg)
* Severe heart failure (e.g. LVEF \< 20%)
* Emergency surgery

Where this trial is running

Athens, Attica

• 2nd University Department of Anesthesiology, Attikon University Hospital — Athens, Attica, Greece (Recruiting)

Study contacts

• Principal investigator: Georgia Ntalamagka, MD — Attikon Hospital
• Study coordinator: Georgia Ntalamagka, MD

Conditions Intraoperative Hypotension; Perioperative Hemodynamic Optimization; Goal-Directed Hemodynamic Therapy; Hypotension Prediction Index; Assisted Fluid Management; Invasive Arterial Pressure Monitoring; Artificial Intelligence; Perioperative Care