Using a hypotension prediction algorithm during major abdominal surgery

The Hypotension Prediction Index in Major Abdominal Surgery - a Prospective Randomized Clinical Trial.

This trial will test whether a machine-learning Hypotension Prediction Index versus arterial pressure cardiac output monitoring can reduce low blood pressure during major abdominal surgery in adults with higher surgical risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Poznan University of Medical Sciences (Academic / other)
• Locations: 1 site (Poznan, Poznań)
• Trial ID: NCT06247384 on ClinicalTrials.gov

What this trial studies

This randomized trial compares two advanced intraoperative hemodynamic monitoring strategies in patients having elective major abdominal surgery: arterial pressure cardiac output monitoring with the FloTrac sensor versus the Hypotension Prediction Index (HPI) algorithm. Patients meeting inclusion criteria (expected surgery >2 hours or significant blood loss/transfusion needs and ASA III–IV) are randomized to one of the two monitoring approaches during anesthesia. The primary focus is whether use of the HPI can predict and prevent episodes of mean arterial pressure falling below 65 mmHg, compared with the reactive APCO-guided management. Outcomes include the rate and duration of intraoperative hypotension and related perioperative complications.

Who should consider this trial

Good fit: Adults eligible are those scheduled for elective major abdominal surgery expected to last over two hours or with anticipated significant blood loss/transfusion needs, with ASA physical status III or IV and able to give informed consent.

Not a fit: Patients with persistent atrial fibrillation or other arrhythmias, severe valvular disease, heart failure with ejection fraction below 35%, pregnant patients, minors, or those unable to have the required monitoring are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, using the Hypotension Prediction Index could reduce episodes of intraoperative low blood pressure and lower the risk of complications such as myocardial injury, stroke, and acute kidney injury.

How similar studies have performed: Prior randomized and observational studies of the Hypotension Prediction Index have shown reductions in intraoperative hypotension in some settings, but results have varied and are not uniformly conclusive.

Eligibility criteria

Inclusion Criteria:

* Patients qualified for elective major abdominal surgery, defined as an expected duration of more than two hours, an estimated blood loss of \>15% of blood volume, or an expected transfusion requirement of at least two packed red blood cells with general or combined anaesthesia.
* Patients with American Society of Anesthesiologists (ASA) status III or IV.
* Written informed consent.

Exclusion Criteria:

* Patients under 18 years
* Lack of health insurance
* Pregnancy
* Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \< 35 %
* Persistent atrial fibrillation and other arrhythmias impairing arterial pressure cardiac output monitoring

Where this trial is running

Poznan, Poznań

• Department of Anesthesiology, Intensive Therapy and Pain Management — Poznan, Poznań, Poland (Recruiting)

Study contacts

• Study coordinator: Jakub Szrama, Ph.D.

Conditions Hypotension During Surgery; hypotension prediction index; major abdominal surgery; arterial pressure cardiac output; intraoperative hypotension