SMART TRENDS Study

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.

A multicenter, interventional, feasibility comparison with historical controls

Study Overview

• Status: Recruiting
• Conditions: Moderate to High-risk Noncardiac Surgery
• Intervention / Treatment: Device: Acumen HPI Smart Alerts and Smart Trends Software

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Johnson; Phone Number: 949-250-0858; Email: SMART_TRENDS_Study@edwards.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Completed
      • UC Davis Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Akshar Patel
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Contact: Katherine Nowak, PhD
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Miriam Treggiari, MD
    • Winston-Salem, North Carolina, United States, 27157
      • Completed
      • Wake Forest Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 997239
      • Completed
      • Oregon Health & Science University
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Recruiting
      • Prisma Health
      • Contact: Kyle J Adams
  • Washington
    • Seattle, Washington, United States, 98195
      • Completed
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: SMART TRENDS Arm; Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPI Smart Alert	The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.	From start to end of non-cardiac surgery

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No