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NCT03469570 Clinical Trial

Assisted Fluid Management IDE Study

Abdominal Surgery Clinical Trial

— AFM  

Official title:
A Validation of the Assisted Fluid Management Feature

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03469570
Other study ID # 2017-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2018
Est. completion date January 25, 2019

Study information
Verified date May 2019
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 330
Est. completion date January 25, 2019
Est. primary completion date December 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design

Related Conditions & MeSH terms

Intervention

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.

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

Sponsors (1)
Lead Sponsor Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):139-44. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of the Assisted Fluid Management Feature: Stroke volume change meeting the clinician-selected fluid strategy Stroke volume change meeting the clinician-selected fluid strategy 30 Day follow-up
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