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Completed

NCT Number: NCT03469570

Assisted Fluid Management IDE Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda Health University, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

Device

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

Primary outcomes

  1. Effectiveness of the Assisted Fluid Management Feature

    Time frame: 30 Day follow-up

    Stroke volume change meeting the clinician-selected fluid strategy

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

A Validation of the Assisted Fluid Management Feature

Acronym: AFM

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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