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Hypotension Prediction Index (HPI) SMART-BP Trial

NCT05105477 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2024-03-25

Study results available
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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

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-12-15
Completion
2022-12-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105477 on ClinicalTrials.gov