Moderate to High-risk Noncardiac Surgery
Conditions
Brief summary
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
Interventions
Non-protocolized standard of care to treat subjects
The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
Sponsors
Edwards Lifesciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Age \>18 years 3. ASA Physical Status \> 2 4. Noncardiac surgery with expected surgery duration \> 2 hours (example include: orthopedic, spine, urology, and general surgery) 5. Planned blood pressure monitoring with an arterial line catheter; 6. General anesthesia;
Exclusion criteria
1. Participating in another interventional Trial; 2. Contraindication to arterial blood pressure monitoring; 3. Subjects with a physical site area too limited for proper Sensor placement 4. Serum creatine \> 175 μmol/L (\>2.0 mg/dL) or CKD stage \> 3A 5. Scheduled for intracranial surgery with permissive hypotension; 6. Patient who is confirmed to be pregnant and/or nursing mothers; 7. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s); 8. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; 9. Emergency surgery; 10. Require beach-chair positioning; 11. Scheduled for cardiac surgeries 12. Have previously participated in the SMART-BP trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. | From post non-cardiac surgery to 30 days. | A composite of 30-day moderate-to-severe perfusion related postoperative complications. |
Countries
United States
Participant flow
Pre-assignment details
At the time of study termination, 407 subjects were enrolled, which included 369 pivotal subjects. Data from the pilot subjects were not analyzed for study outcomes. Only 369 subjects were pivotal subjects that were analyzed for study outcomes. The tables below display the information and results from the 369 pivotal subjects.
Participants by arm
| Arm | Count |
|---|---|
| HPI Arm Acumen HPI Software Feature: The Acumen HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor. | 187 |
| Non-HPI Arm Non-protocolized standard of care management per clinician and provider judgement | 182 |
| Total | 369 |
Baseline characteristics
| Characteristic | HPI Arm | Non-HPI Arm | Total |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | 63 years |
| Race/Ethnicity, Customized African American or Black | 18 Participants | 11 Participants | 29 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Declined to identify | 9 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 150 Participants | 158 Participants | 308 Participants |
| Region of Enrollment United States | 187 Participants | 182 Participants | 369 Participants |
| Sex: Female, Male Female | 86 Participants | 77 Participants | 163 Participants |
| Sex: Female, Male Male | 101 Participants | 105 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 187 | 1 / 182 |
| other Total, other adverse events | 19 / 187 | 21 / 182 |
| serious Total, serious adverse events | 48 / 187 | 38 / 182 |
Outcome results
Primary
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Time frame: From post non-cardiac surgery to 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HPI Arm | A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. | 19 participants with post-op complications |
| Non-HPI Arm | A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications. | 19 participants with post-op complications |