Hypotension Prediction Index Study (HPI Study)

Study Overview
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Brief Summary
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A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)

Official Title
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Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring With Acumen™ Hypotension Prediction Index Feature Software

Conditions
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Hypotension

Intervention / Treatment
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* Device: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent; Age ≥ 18 years; ASA Physical Status 3 or 4; Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery); Planned pressure monitoring with an arterial line; General anesthesia; Surgery duration expected to last ≥ 3 hours from induction; Planned overnight hospitalization. Exclusion Criteria: Participating in another (interventional) study; Contraindication to the invasive blood pressure monitoring; Patient who is confirmed to be pregnant and/or nursing mothers; Emergency surgery; Known clinically important intra-cardiac shunts; Patient in whom an intraoperative MAP target will be < 65 mmHg; Known aortic stenosis with valve area ≤ 1.5 cm2; Known moderate to severe aortic regurgitation; Known moderate to severe mitral regurgitation; Known moderate to severe mitral stenosis; Patient or surgical procedure type known as an SVV limitation (5) (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6); Current persistent atrial fibrillation; Known acute congestive heart failure; Craniotomy; Surgery duration expected to last < 3 hours; Burn surgeries; Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software|EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Intraoperative Hypotension | Duration (t [min]) reduction of intraoperative hypotension (defined as MAP < 65 mmHg for at least 1 minute) as compared with a historic retrospective control group | Duration of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Hypotension in Each Subject | The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum. | Duration of Surgery |