Hypotension Prediction Index Study (HPI Study)

Completed

Conditions studied: Hypotension

In brief

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)

Key facts

Study ID

NCT03805217

Run by

Edwards Lifesciences

People needed

485

Starts

2019-05-16

Expected to finish

2020-03-17

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Health Care — Stanford, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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