SMART TRENDS Study

Not Applicable

Active, not recruiting

• Conditions: Moderate to High-risk Noncardiac Surgery

• Registration Number: NCT05957406
• Lead Sponsor: Edwards Lifesciences

Brief Summary

A multicenter, interventional, feasibility comparison with historical controls

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-11
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-20
• Last Update Posted: 2025-10-22
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 296

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
HPI Smart Alert	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.

Trial Locations

Locations (8)

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