NCT05105477

Hypotension Prediction Index (HPI) SMART-BP Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to High-risk Noncardiac Surgery

Interventions

Type	Name	Description
DEVICE	AcumenTM HPI Software Feature	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.
OTHER	Non-protocolized Standard of Care	Non-protocolized standard of care to treat subjects

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2021-11-03
• Last updated: 2024-03-25
• Results posted: 2024-03-25

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study