Trials / Completed
CompletedNCT05957406
SMART TRENDS Study
Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 296 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, interventional, feasibility comparison with historical controls
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acumen HPI Smart Alerts and Smart Trends Software | 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. |
| DEVICE | The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff | Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff |
Timeline
- Start date
- 2023-07-11
- Primary completion
- 2025-10-27
- Completion
- 2025-10-27
- First posted
- 2023-07-24
- Last updated
- 2025-12-22
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05957406. Inclusion in this directory is not an endorsement.