Trials / Completed
CompletedNCT03805217
Hypotension Prediction Index Study (HPI Study)
Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 485 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software | EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2020-03-17
- Completion
- 2020-03-17
- First posted
- 2019-01-15
- Last updated
- 2024-10-18
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03805217. Inclusion in this directory is not an endorsement.