SMART TRENDS Study

Edwards Lifesciences

Status: Enrolling

Conditions: Moderate to High-risk Noncardiac Surgery

Treatments: Device: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff; Device: Acumen HPI Smart Alerts and Smart Trends Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT05957406

2023-05

Details and patient eligibility

About

A multicenter, interventional, feasibility comparison with historical controls

Enrollment: 244 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

SMART TRENDS - Acumen IQ Sensor

Other group

Description:

Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Treatment:

Device: Acumen HPI Smart Alerts and Smart Trends Software

SMART TRENDS - Acumen IQ Cuff

Other group

Description:

Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Treatment:

Device: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff