Assisted Fluid Management IDE Study

Edwards Lifesciences330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

330

Conditions

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

Interventions

EV1000 Clinical Platform with Assisted Fluid Management (AFM) FeatureDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Loma Linda Health University

Loma Linda, California, United States

University of California, Davis

Sacramento, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Effectiveness of the Assisted Fluid Management Feature

Stroke volume change meeting the clinician-selected fluid strategy

Time frame: 30 Day follow-up

Data from ClinicalTrials.gov

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