Assisted Fluid Management IDE Study

Completed · Not applicable

Conditions studied: Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery

In brief

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.

Key facts

Study ID

NCT03469570

Run by

Edwards Lifesciences

People needed

330

Starts

2018-04-19

Expected to finish

2019-01-25

Last updated by the study team

2024-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loma Linda Health University — Loma Linda, California, United States
• University of California, Davis — Sacramento, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Greenville Health System, Greenville Memorial Hospital — Greenville, South Carolina, United States
• The University of Texas Southwestern at Clements — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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