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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 296
- Locations
- 16
- Primary Endpoint
- HPI Smart Alert
Study Overview
Brief Summary
A multicenter, interventional, feasibility comparison with historical controls
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Masking Description
HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
SMART TRENDS - Acumen IQ Sensor
Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Intervention: Acumen HPI Smart Alerts and Smart Trends Software (Device)
SMART TRENDS - Acumen IQ Cuff
Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Intervention: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff (Device)
Outcomes
Primary Outcomes
HPI Smart Alert
Time Frame: From start to end of non-cardiac surgery
The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.
Secondary Outcomes
No secondary outcomes reported