Hypotension Prediction Index versus standard advanced blood pressure monitoring during major abdominal aortic surgery

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

This trial will test whether using a Hypotension Prediction Index device can help prevent low blood pressure in adults having major elective abdominal aortic surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Poznan University of Medical Sciences (Academic / other)
• Locations: 1 site (Poznan, Poznań)
• Trial ID: NCT07510451 on ClinicalTrials.gov

What this trial studies

Adults scheduled for elective open or endovascular abdominal aortic repair expected to last more than two hours will receive advanced intraoperative haemodynamic monitoring. Participants will be assigned to haemodynamic management guided by the Hypotension Prediction Index (HPI) using Acumen IQ/FloTrac technology or to standard advanced pulse‑contour/APCO-guided monitoring. The HPI arm uses real‑time predictive alarms to prompt earlier interventions to avoid hypotension, while the control arm follows usual APCO-derived parameters and clinician judgment. Outcomes will focus on intraoperative hypotension incidence and related clinical events during and shortly after surgery.

Who should consider this trial

Good fit: Adults aged 18 or older with ASA physical status III or IV who are scheduled for elective major open or endovascular abdominal aortic surgery expected to exceed two hours and who can give informed consent are ideal candidates.

Not a fit: Patients with emergency surgery, significant valvular disease, severe left ventricular dysfunction (LVEF <35%), permanent atrial fibrillation, pregnancy, or inability to consent are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce episodes of intraoperative hypotension and lower the risk of organ injury and postoperative complications.

How similar studies have performed: HPI-guided monitoring has shown promise in reducing intraoperative hypotension in other surgical settings, but its use specifically in major aortic surgery remains less well tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. American Society of Anesthesiologists (ASA) physical status classification III or IV
3. Scheduled for elective major abdominal aortic surgery (open or endovascular repair) with an expected surgical duration exceeding 2 hours
4. Able to provide written informed consent

Exclusion Criteria:

1. Emergency or urgent surgery
2. Pregnancy or breastfeeding or positive/uncertain pregnancy test
3. 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
4. Severe heart failure with left ventricular ejection fraction \< 35%
5. Permanent atrial fibrillation (reduces accuracy of pulse contour analysis)
6. Inability to provide informed consent
7. Participation in another interventional trial that may influence haemodynamic management or study outcomes

Where this trial is running

Poznan, Poznań

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

Study contacts

• Study coordinator: Jakub Szrama, PhD

Conditions 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; hypotension; Hypotension Prediction Index; Acumen IQ; FloTrac; haemodynamic monitoring,; aortic abdominal surgery