Assisted Fluid Management IDE Study
Purpose
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.
Conditions
- Non-Cardiac/ Non-Thoracic Surgery
- Abdominal Surgery
- Pelvic Surgery
- Major Peripheral Vascular Surgery
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Assisted Fluid Management |
|
More Details
- Status
- Completed
- Sponsor
- Edwards Lifesciences
Study Contact
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.