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NCT03805217 · ClinicalTrials.gov registry record
Hypotension Prediction Index Study (HPI Study)
A clinical trial, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- 485
- Enrollment target
NCT03805217: Completed study, sponsored by Edwards Lifesciences.
NCT03805217 is a clinical trial that has completed, run by Edwards Lifesciences. The registered enrollment target is 485 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03805217 has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- 485 participants
- Enrollment target
Study 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)
Primary Outcome
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
Interventions
- DEVICE EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2020-03-17 |
What the finished NCT03805217 record still lists
NCT03805217 is an observational study that tracks outcomes without assigning an intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software is the first listed.
NCT03805217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03805217 about?
NCT03805217 is a clinical study titled "Hypotension Prediction Index Study (HPI Study)". 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)
What is the current status of trial NCT03805217?
This trial is currently completed. The enrollment target is 485 participants. The study started on 2019-05-16. Estimated completion is 2020-03-17.
What interventions are being tested in trial NCT03805217?
The interventions under investigation include: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software (DEVICE).
Who is sponsoring clinical trial NCT03805217?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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