The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery

Recruiting now · Not applicable

Conditions studied: Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours

In brief

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.

Key facts

Study ID: NCT07510451
Run by: Poznan University of Medical Sciences
People needed: 200
Starts: 2026-04-12
Expected to finish: 2028-06-01
Last updated by the study team: 2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Emergency or urgent surgery
Pregnancy or breastfeeding or positive/uncertain pregnancy test
Haemodynamically significant valvular heart disease:
Severe aortic stenosis (aortic valve area < 1.5 cm\^2)
Moderate to severe aortic regurgitation
Moderate to severe mitral regurgitation
Moderate to severe mitral stenosis
Severe heart failure with left ventricular ejection fraction < 35%
Permanent atrial fibrillation (reduces accuracy of pulse contour analysis)
Inability to provide informed consent
Participation in another interventional trial that may influence haemodynamic management or study outcomes

Where it is running

Department of Anesthesiology and Intensive Therapy — Poznan, Poznań, Poland (enrolling)

Full record on ClinicalTrials.gov

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