Status:
COMPLETED
Hypotension Prediction Index Study (HPI Study)
Lead Sponsor:
Edwards Lifesciences
Conditions:
Hypotension
Eligibility:
All Genders
18+ years
Brief 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 red...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 17 2020
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT03805217
Start Date
May 16 2019
End Date
March 17 2020
Last Update
October 18 2024
Active Locations (11)
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1
Stanford Health Care
Stanford, California, United States, 94305
2
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06510
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114