N/A
N=330
Assisted Fluid Management IDE Study
Non-Cardiac/ Non-Thoracic Surgery · Abdominal Surgery · Pelvic Surgery · Major Peripheral Vascular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03469570 ↗Enrolled (actual)
330
Serious AEs
28.0%
Results posted
Nov 2024
Primary outcome: Primary: Effectiveness of the Assisted Fluid Management Feature — 307 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of the Assisted Fluid Management Feature |
307 | — |
Summary
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Eligibility Criteria
Inclusion Criteria
- Be ≥ 18 years of age
- Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction
- Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form.
Exclusion Criteria
- Are < 18 years of age
- Emergent or cardiovascular surgical procedure
- Are pregnant
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study)
- Refusal of patient or authorized representative to sign consent
Data sourced from ClinicalTrials.gov (NCT03469570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.