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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07301307
Enrollment
100
Registered
2025-12-24
Start date
2026-03-15
Completion date
2027-03-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Hypotension

Keywords

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

Brief 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.

Detailed description

Intraoperative hypotension is a common complication during general anesthesia and is associated with an increased risk of postoperative organ dysfunction (acute kidney injury, myocardial ischemia). Even short episodes of mean arterial pressure (MAP) below accepted thresholds have been shown to adversely affect patient outcomes. The Hypotension Prediction Index , (HPI)is a software that predicts the likelihood of hypotension minutes before it occurs, based on the arterial waveform. Thus clinicians have the opportunity to identify patients at risk of hypotension and intervene early. The Assisted Fluid Management (AFM) software is designed to optimize perioperative fluid administration based on the Frank-Starling curve. The AFM provides guidance on crystalloid admininistration only when it is expected to increase stroke volume and cardiac output. This prospective , randomized study evaluates whether the use of HPI coupled with AFM within a goal directed hemodynamic protocol improves perioperative hemodynamic management and reduces the incidence and duration of adult patients undergoing surgery under general anesthesia. A total of 100 adult patients will be enrolled , for elective surgery with invasive blood pressure monitoring and intraoperative mean arterial pressure target of at least 65 mm Hg. Patients in the intervention group will undergo goal directed hemodynamic management guided by HPI and AFM algorithms via the Hemosphere monitor and Acumen IQ sensor. The AFM software will determine the timing of fluid administration. Elevated HPI values indicating impending hypotension will be managed in a targeted manner with fluids, vasopressors or inotropes. Patients in the control group will receive conventional hemodynamic management , based on clinical judgement, in accordance with international guidelines. Although an Acumen IQ sensor will be placed, HPI and AFM indications will not be visible to the attending anesthesiologist and will not influence clinical decision making. Intraoperative hemodynamic data will be continuously recorded in both groups. A member of the research team will be present to supervise the procedure. The primary outcome is the time-weighted average of hypotension, defined as MAP below 65 mm Hg for at least one minute. Secondary outcomes include the incidence and duration of hypotension, type and dose of administered therapies and protocol adherence.

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.

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER
Attikon Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Clinicians managing patients are aware of group assignment, as treatment decisions depend on the intervention. Outcome assessors collect data but do not influence group allocation.

Intervention model description

Participants will be randomly assigned in a 1:1 ratio to one of two study groups. One group will receive goal-directed hemodynamic therapy using the Hypotension Prediction Index and Assisted Fluid Management software. The control group will receive conventional intraoperative hemodynamic management. Each participant will remain in the assigned group for the duration of the study without crossover.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time-weighted average of intraoperative hypotensionIntraoperatively, starting 10 minutes after anesthesia induction or start of sedationTime weighted average spent in hypotension, defined as mean arterial pressure (MAP) \<65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.

Secondary

MeasureTime frameDescription
Incidence of hypotensionIntraoperatively, starting 10 minutes after anesthesia induction or start of sedationIncidence of hypotension, defined as MAP \<65mmHg for ≥ 1min.
Time spent in hypotensionIntraoperatively, starting 10 minutes after anesthesia induction or start of sedationTime spent in hypotension, in minutes, defined as MAP \<65mmHg for ≥ 1min
Choice of therapy (fluids/medications)Intraoperatively, starting 10 minutes after anesthesia induction or start of sedationMedication used to prevent/treat hypotension. A study member is present at the OR to make notes.
Dose of therapy (fluids/medications)Intraoperatively, starting 15 minutes after anesthesia induction.Dose of medication used to prevent/treat hypotension.
Protocol deviationsIntraoperatively, starting 15 minutes after anesthesia inductionDiagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.

Countries

Greece

Contacts

CONTACTGeorgia Ntalamagka, MD
geo.dalamaga@gmail.com+306978210163
PRINCIPAL_INVESTIGATORGeorgia Ntalamagka, MD

Attikon Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026