Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software | Device | EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects recruited and enrolled should be classified as American Society of Anesthesiologist (ASA) physical status 3-4 who are scheduled for moderate-to-high-risk non-cardiac surgery and will be receiving pressure monitoring with an arterial line. Potentially qualifying patients will be evaluated during their preoperative anesthesia clinic visits.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tina Abdelnour, MS, BSN | Edwards Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States | ||
| UCHealth University of Colorado Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38439069 | Derived | Bao X, Kumar SS, Shah NJ, Penning D, Weinstein M, Malhotra G, Rose S, Drover D, Pennington MW, Domino K, Meng L, Treggiari M, Clavijo C, Wagener G, Chitilian H, Maheshwari K; HPI Study Team. AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial. Perioper Med (Lond). 2024 Mar 4;13(1):13. doi: 10.1186/s13741-024-00369-9. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Aurora |
| Colorado |
| 80045 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 97239 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |