Assisted Fluid Management IDE Study

Not Applicable

Completed

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

Interventions: Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

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 in the validation study will have their fluid management decisions guided by the AFM Feature.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Assisted Fluid Management	EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of the Assisted Fluid Management Feature	30 Day follow-up	Stroke volume change meeting the clinician-selected fluid strategy

Secondary Outcome Measures

Name	Time	Method

Locations (10): Greenville Health System, Greenville Memorial Hospital
🇺🇸
Greenville, South Carolina, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
University of California, Davis
🇺🇸
Sacramento, California, United States
Loma Linda Health University
🇺🇸
Loma Linda, 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
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern at Clements
🇺🇸
Dallas, Texas, United States