Abdominal Surgery, Major Peripheral Vascular Surgery, Non-Cardiac/ Non-Thoracic Surgery, Pelvic Surgery
Conditions
Keywords
Non-Cardiac, Non-Thoracic, Fluid Management, Perioperative Goal Directed Therapy
Brief 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.
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.
Interventions
DEVICEEV1000 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.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the Assisted Fluid Management Feature | 30 Day follow-up | Stroke volume change meeting the clinician-selected fluid strategy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Assisted Fluid Management 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. | 330 |
| Total | 330 |
Baseline characteristics
| Characteristic | Assisted Fluid Management |
|---|---|
| Age, Continuous | 66 years |
| Race/Ethnicity, Customized Rance and Ethnicity African American | 22 Participants |
| Race/Ethnicity, Customized Rance and Ethnicity Asian | 2 Participants |
| Race/Ethnicity, Customized Rance and Ethnicity Not Reported | 1 Participants |
| Race/Ethnicity, Customized Rance and Ethnicity Other | 5 Participants |
| Race/Ethnicity, Customized Rance and Ethnicity White | 284 Participants |
| Sex: Female, Male Female | 131 Participants |
| Sex: Female, Male Male | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 314 |
| other Total, other adverse events | 226 / 314 |
| serious Total, serious adverse events | 88 / 314 |
Outcome results
Primary
Effectiveness of the Assisted Fluid Management Feature
Stroke volume change meeting the clinician-selected fluid strategy
Time frame: 30 Day follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Assisted Fluid Management | Effectiveness of the Assisted Fluid Management Feature | 307 Participants |