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.
Age > 18 years
Intraoperative monitoring > 2 hours or general anesthesia > 2 hours
Invasive arterial pressure monitoring
Target MAP ≥ 65 mm Hg intraoperatively
Target MAP other than 65 mm Hg
Severe preoperative hypotension (MAP < 65 mm Hg)
Severe heart failure (e.g. LVEF < 20%)
Emergency surgery
Parallel
Acumen IQ sensor with Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM) software
DeviceThe 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.
Conventional Intraoperative Hemodynamic management
Other interventionParticipants 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.
Time-weighted average of intraoperative hypotension
Time weighted average spent in hypotension, defined as mean arterial pressure (MAP) \<65mmHg for ≥ 1min, measures using the Acumen IQ sensor and Hemosphere monitor.
Incidence of hypotension
Incidence of hypotension, defined as MAP \<65mmHg for ≥ 1min.
Time spent in hypotension
Time spent in hypotension, in minutes, defined as MAP \<65mmHg for ≥ 1min
Choice of therapy (fluids/medications)
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes.
Dose of therapy (fluids/medications)
Dose of medication used to prevent/treat hypotension.
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National and Kapodistrian University of Athens
Lead sponsor
Attikon Hospital
Sponsor institution
Attikon Hospital
Collaborator
