Hypotension Prediction Index (HPI) SMART-BP Trial

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2022-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to High-risk Noncardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HPI Arm

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

Group Type EXPERIMENTAL

AcumenTM HPI Software Feature

Intervention Type DEVICE

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.

Non-HPI arm

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

Group Type PLACEBO_COMPARATOR

Non-protocolized Standard of Care

Intervention Type OTHER

Non-protocolized standard of care to treat subjects

Interventions

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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.

Intervention Type DEVICE

Non-protocolized Standard of Care

Non-protocolized standard of care to treat subjects

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No