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The Hypotension Prediction Index Software Compared With Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery: A Prospective Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The standard procedure during general anesthesia is to monitor vital functions, including cardiovascular functions such as cardiac electrical activity, using continuous ECG recording, blood pressure measurement with a sphygmomanometer, heart rate measurement, and tissue oxygenation measurement with a pulse oximeter. These are non-invasive methods, which are often insufficient in the case of extensive procedures within the abdominal aorta. In such cases, the anesthesiologist additionally use direct blood pressure measurements and central venous pressure measurements. To perform these measurements, it is necessary to insert a cannula into an artery (usually the radial artery) and a catheter into the central veins (through the internal jugular or subclavian vein). Vascular cannulation is an invasive method and may be associated with complications such as vascular thrombosis, infection at the puncture site or catheter-related infections, pneumothorax, air embolism, cardiac arrhythmias, neuropathies, hematomas, and bleeding. At the same time, they allow for a more accurate assessment of cardiovascular function and the implementation of appropriate treatment, including the administration of large amounts of infusion fluids, vasoconstrictors, and cardiac support drugs. In the current study, the investigators will additionally use a special sensor and monitor to assess the heart's performance (cardiac output) and its response to the treatment used, optimizing and supporting the circulatory system. This monitoring requires the insertion of a catheter into a central vein and artery, which is necessary during vascular surgery procedures and does not involve any additional invasive procedures. In the postoperative period, the investigators will analyze the frequency of abnormalities in laboratory tests routinely collected after surgery and the function of the central nervous system by performing simple non-invasive cognitive function tests. The benefits of using the method of assessing the patient's response to surgery and anesthesia in presented study are related to increased safety for each patient and improved perioperative treatment for all patients undergoing surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• American Society of Anesthesiologists (ASA) physical status classification III or IV

• Scheduled for elective major abdominal aortic surgery (open or endovascular repair) with an expected surgical duration exceeding 2 hours

• Able to provide written informed consent

Locations
Other Locations
Poland
Department of Anesthesiology and Intensive Therapy
RECRUITING
Poznan
Contact Information
Primary
Jakub Szrama, PhD
jakub.szrama@usk.poznan.pl
+48611613280
Backup
Mariusz Gezela
mariusz.gezela@usk.poznan.pl
+48611613250
Time Frame
Start Date: 2026-04-12
Estimated Completion Date: 2028-06
Participants
Target number of participants: 200
Treatments
Active_comparator: HPI-guided haemodynamic management (HPI group)
Patients allocated to the HPI group will receive haemodynamic monitoring using the Acumen IQ sensor (Edwards Lifesciences, Irvine, CA, USA) connected to the radial arterial line. The Acumen IQ system provides all parameters available with the FloTrac sensor, plus additional advanced metrics including dynamic arterial elastance (Ea\_dyn), the rate of ventricular pressure change (dP/dt), and the Hypotension Prediction Index (HPI).~The HPI is a machine learning-derived value ranging from 0 to 100 that represents the probability of MAP falling below 65 mmHg within the next 15 minutes. When HPI exceeds 85, the system generates an alert and displays a secondary screen presenting real-time haemodynamic parameters and suggested interventions. Haemodynamic management in the HPI group will follow a structured protocol incorporating both predictive (HPI-triggered) and reactive (MAP-based) components.
Active_comparator: standard arterial pressure-derived cardiac output monitoring (FloTrac group)
Patients allocated to the FloTrac group will receive haemodynamic monitoring using the FloTrac sensor (Edwards Lifesciences, Irvine, CA, USA) connected to the radial arterial line. The FloTrac system provides continuous measurements of cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI), stroke volume variation (SVV), systemic vascular resistance (SVR), and systemic vascular resistance index (SVRI) based on arterial pressure waveform analysis.~Haemodynamic management in the FloTrac group will follow a structured protocol designed to maintain MAP ≥ 75 mmHg while avoiding excessive hypertension (target MAP ≤ 100 mmHg).
Related Therapeutic Areas
Sponsors
Leads: Poznan University of Medical Sciences

This content was sourced from clinicaltrials.gov