Clinical trial NCT05957406: SMART TRENDS Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Moderate to High-risk Noncardiac Surgery
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: HemoSphere Advanced Monitor with Acumen Hypotension Prediction Index (HPI) software feature, and Acumen IQ sensor
Primary purpose: OTHER

Brief summary: A multicenter, interventional, feasibility comparison with historical controls


Eligibility 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)

Primary outcomes:
measure: HPI Smart Alert
timeFrame: From start to end of non-cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Edwards Lifesciences
name: Tina Abdelnour, MS, BSN
role: STUDY_DIRECTOR
References: