Status:
COMPLETED
Assisted Fluid Management IDE Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Non-Cardiac/ Non-Thoracic Surgery
Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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. Subjects enrolled...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2019
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT03469570
Start Date
April 19 2018
End Date
January 25 2019
Last Update
November 8 2024
Active Locations (10)
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1
Loma Linda Health University
Loma Linda, California, United States, 92354
2
University of California, Davis
Sacramento, California, United States, 95817
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Stony Brook Medicine
Stony Brook, New York, United States, 11794-8480