Assisted Fluid Management IDE Study (AFM)

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery; Pelvic Surgery; Non-Cardiac/ Non-Thoracic Surgery; Major Peripheral Vascular Surgery
• Intervention / Treatment: Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

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.

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda Health University
    • Sacramento, California, United States, 95817
      • University of California, Davis
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • Stony Brook, New York, United States, 11794-8480
      • Stony Brook Medicine
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System, Greenville Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern at Clements

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assisted Fluid Management; Subjects enrolled in the validation study will have their fluid management decisions guided by the Acumen™ Assisted Fluid Management Feature. The Principal Investigator will accept or decline fluid recommendations.	Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature; Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the Assisted Fluid Management Feature	Stroke volume change meeting the clinician-selected fluid strategy	30 Day follow-up

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Study Director: Tina Abdelnour, MS, BSN, Edwards Lifesciences

Publications and helpful links

General Publications

• Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Fluid Management; Perioperative Goal Directed Therapy; Non-Cardiac; Non-Thoracic
• Other Study ID Numbers: 2017-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes