Hypotension
Conditions
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 reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
Interventions
DEVICEEV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
Sponsors
Edwards Lifesciences
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent; 2. Age ≥ 18 years; 3. ASA Physical Status 3 or 4; 4. Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery); 5. Planned pressure monitoring with an arterial line; 6. General anesthesia; 7. Surgery duration expected to last ≥ 3 hours from induction; 8. Planned overnight hospitalization.
Exclusion criteria
1. Participating in another (interventional) study; 2. Contraindication to the invasive blood pressure monitoring; 3. Patient who is confirmed to be pregnant and/or nursing mothers; 4. Emergency surgery; 5. Known clinically important intra-cardiac shunts; 6. Patient in whom an intraoperative MAP target will be \< 65 mmHg; 7. Known aortic stenosis with valve area ≤ 1.5 cm2; 8. Known moderate to severe aortic regurgitation; 9. Known moderate to severe mitral regurgitation; 10. Known moderate to severe mitral stenosis; 11. 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); 12. Current persistent atrial fibrillation; 13. Known acute congestive heart failure; 14. Craniotomy; 15. Surgery duration expected to last \< 3 hours; 16. Burn surgeries; 17. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); 18. Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Intraoperative Hypotension | Duration of Surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Hypotension in Each Subject | Duration of Surgery | 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. |
Countries
United States
Outcome results
None listed