Trials / Recruiting

RecruitingNCT07510451

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

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 200 (estimated)

Sponsor: Poznan University of Medical Sciences · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DEVICE	HPI guided heamodynamic monitoring	The investigators hypothesise that HPI-guided haemodynamic management, when implemented with protocol refinements to mitigate hypertensive overcorrection, will reduce the burden of intraoperative hypotension compared with standard APCO monitoring in patients undergoing major abdominal aortic surgery. Secondary objectives include evaluation of postoperative organ injury, assessment of intraoperative hypertension as a safety outcome, and characterisation of fluid and vasopressor requirements. By testing this hypothesis in a rigorously designed, adequately powered trial, the investigators aim to clarify whether predictive haemodynamic monitoring offers clinically meaningful advantages over current reactive approaches in this high-risk population.
DEVICE	Standard Heamodynamic Managament according to APCO Monitoring	Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg

Timeline

Start date: 2026-04-12
Primary completion: 2028-03-01
Completion: 2028-06-01
First posted: 2026-04-03
Last updated: 2026-04-15

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT07510451. Inclusion in this directory is not an endorsement.