Assisted Fluid Management IDE Study (AFM)

Edwards Lifesciences

Status: Completed

Conditions: Pelvic Surgery; Non-Cardiac/ Non-Thoracic Surgery; Abdominal Surgery; Major Peripheral Vascular Surgery

Treatments: Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

Study type: Interventional

Funder types: Industry

Identifiers

NCT03469570

2017-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Assisted Fluid Management

Experimental group

Description:

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.

Treatment:

Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature