Hypotension Prediction Index (HPI) SMART-BP Trial

Edwards Lifesciences

Status: Terminated

Conditions: Moderate to High-risk Noncardiac Surgery

Treatments: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05105477

2021-04

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
2. Age >18 years
3. ASA Physical Status > 2
4. Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
5. Planned blood pressure monitoring with an arterial line catheter;
6. General anesthesia;

Exclusion criteria

1. Participating in another interventional Trial;
2. Contraindication to arterial blood pressure monitoring;
3. Subjects with a physical site area too limited for proper Sensor placement
4. Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
5. Scheduled for intracranial surgery with permissive hypotension;
6. Patient who is confirmed to be pregnant and/or nursing mothers;
7. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
8. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
9. Emergency surgery;
10. Require beach-chair positioning;
11. Scheduled for cardiac surgeries
12. Have previously participated in the SMART-BP trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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407 participants in 2 patient groups, including a placebo group

HPI Arm

Experimental group

Description:

AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Treatment:

Device: AcumenTM HPI Software Feature

Non-HPI arm

Placebo Comparator group

Description:

Non-protocolized standard of care management per clinician and provider judgement

Treatment:

Other: Non-protocolized Standard of Care