Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
296 participants
INTERVENTIONAL
2023-07-11
2025-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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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.
Acumen HPI Smart Alerts and Smart Trends Software
Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor.
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.
The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Interventions
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Acumen HPI Smart Alerts and Smart Trends Software
Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor.
The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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)
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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UC Davis Medical Center
Sacramento, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Duke University
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Prisma Health
Greenville, South Carolina, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Guerra-Londono CE, Hand WR, Fleming N, Davis J, Treggiari MM, Dunkman WJ, Kumar SS, Khanna AK, Yang JT, Domino KB. Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study. BMC Anesthesiol. 2025 Sep 30;25(1):471. doi: 10.1186/s12871-025-03336-z.
Other Identifiers
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2023-05
Identifier Type: -
Identifier Source: org_study_id