Hypotension Prediction Index Study (HPI Study) (NCT03805217) | Clinical Trial Compass
CompletedNot Applicable
Hypotension Prediction Index Study (HPI Study)
United States485 participantsStarted 2019-05-16
Plain-language summary
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)
Who can participate
Age range18 Years
SexALL
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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;