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A multicenter, interventional, feasibility comparison with historical controls
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART TRENDS - Acumen IQ Sensor | Other | Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
|
| SMART TRENDS - Acumen IQ Cuff | Other | Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acumen HPI Smart Alerts and Smart Trends Software | Device | Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor. |
| Measure | Description | Time Frame |
|---|---|---|
| HPI Smart Alert | The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm. | From start to end of non-cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Cohort 2 only:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41029588 | Derived | Guerra-Londono CE, Hand WR, Fleming N, Davis J, Treggiari MM, Dunkman WJ, Kumar SS, Khanna AK, Yang JT, Domino KB. Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study. BMC Anesthesiol. 2025 Sep 30;25(1):471. doi: 10.1186/s12871-025-03336-z. |
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HemoSphere Advanced Monitor with Acumen Hypotension Prediction Index (HPI) software feature, and Acumen IQ sensor
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HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
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|
| The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff | Device | Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff |
|
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Oregon Health & Science University | Portland | Oregon | 997239 | United States |
| Prisma Health | Greenville | South Carolina | 29615 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |