Using advanced monitoring technology for patients undergoing noncardiac surgery
Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
This study is testing if new monitoring technology can help improve care for adults having moderate to high-risk noncardiac surgeries that last at least three hours.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Edwards Lifesciences Industry-sponsored |
| Locations | 8 sites (Sacramento, California and 7 other locations) |
| Trial ID | NCT05957406 on ClinicalTrials.gov |
What this trial studies
This multicenter interventional study aims to evaluate the feasibility of using advanced monitoring technologies, including Acumen HPI Smart Alerts and the HemoSphere platform, in patients undergoing moderate to high-risk noncardiac surgery. The study will compare outcomes with historical controls to assess the effectiveness of these monitoring tools in improving patient management during surgery. Eligible participants will be adults undergoing elective noncardiac surgeries lasting at least three hours, with specific monitoring requirements. The study focuses on enhancing intra-operative hemodynamic management to potentially improve post-operative outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective noncardiac surgery lasting three hours or more, with specific monitoring needs.
Not a fit: Patients who are undergoing emergency surgeries, intracranial or cardiac surgeries, or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of patients during noncardiac surgeries, potentially reducing complications and enhancing recovery.
How similar studies have performed: While this approach is innovative, similar studies utilizing advanced monitoring technologies have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age ≥ 18 years * ASA Physical Status ≥ 2 * Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days * Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion * General anesthesia with tracheal intubation and positive pressure ventilation Exclusion Criteria: * Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors * Planned vasopressor or inotrope infusion during surgery * Contraindication to intra-arterial blood pressure monitoring * Has previously participated in the SMART TRENDS study * Serum creatine \> 2.0 mg/dL (\> 175 μmol/L) or CKD stage \> 3A * Scheduled for intracranial or cardiac surgery * Patient who is known to be pregnant * Patients on mechanical circulatory support * Emergency surgery * Planned beach-chair positioning Additional Exclusion Criteria for Cohort 2 only: * Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease * Finger or hand deformity that prevents proper placement of finger cuff by visual inspection * Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Where this trial is running
Sacramento, California and 7 other locations
- UC Davis Medical Center — Sacramento, California, United States (Active_not_recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Active_not_recruiting)
- Henry Ford Health System — Detroit, Michigan, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (Active_not_recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Prisma Health — Greenville, South Carolina, United States (Active_not_recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Cristina Johnson
- Email: SMART_TRENDS_Study@edwards.com
- Phone: 949-250-0858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.