Hypotension Prediction Index (HPI) SMART-BP Trial

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.

Official Title
-----------------
Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)

Conditions
-----------------
Moderate to High-risk Noncardiac Surgery

Intervention / Treatment
-----------------
* Device: AcumenTM HPI Software Feature
* Other: Non-protocolized Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Age >18 years ASA Physical Status > 2 Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery) Planned blood pressure monitoring with an arterial line catheter; General anesthesia; Exclusion Criteria: Participating in another interventional Trial; Contraindication to arterial blood pressure monitoring; Subjects with a physical site area too limited for proper Sensor placement Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A Scheduled for intracranial surgery with permissive hypotension; Patient who is confirmed to be pregnant and/or nursing mothers; Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; Emergency surgery; Require beach-chair positioning; Scheduled for cardiac surgeries Have previously participated in the SMART-BP trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI Arm<br>AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. | Device: AcumenTM HPI Software Feature<br>* The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.<br>|
| Placebo Comparator: Non-HPI arm<br>Non-protocolized standard of care management per clinician and provider judgement | Other: Non-protocolized Standard of Care<br>* Non-protocolized standard of care to treat subjects<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of 30-day moderate-to-severe perfusion related postoperative complications. | A composite of 30-day moderate-to-severe perfusion related postoperative complications. | From post non-cardiac surgery to 30 days. |