Assisted Fluid Management IDE Study



Status:Active, not recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:April 17, 2018
End Date:April 2019

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A Validation of the Assisted Fluid Management Feature

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.

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.

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
We found this trial at
10
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Dallas, TX
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Greenville, SC
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Loma Linda, California 92354
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Loma Linda, CA
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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Sacramento, CA
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Stony Brook, New York 11794
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Stony Brook, NY
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