Smart Monitoring Software for Noncardiac Surgery Outcomes
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Acumen HPI software for noncardiac surgery outcomes?
The Acumen HPI software, which uses artificial intelligence to predict low blood pressure during surgery, has been shown to reduce the severity and duration of low blood pressure in patients undergoing non-cardiac surgery. Studies indicate that patients monitored with this software experienced fewer complications and shorter hospital stays.12345
Is the Acumen Hypotension Prediction Index software safe for use in humans?
How does the Smart Monitoring Software treatment differ from other treatments for noncardiac surgery outcomes?
The Smart Monitoring Software, specifically the Acumen™ Hypotension Prediction Index (HPI) software, is unique because it uses artificial intelligence to predict and prevent intraoperative hypotension (low blood pressure during surgery) by analyzing blood pressure waveforms. This proactive approach contrasts with traditional methods that react to hypotension after it occurs, potentially reducing complications and improving patient outcomes during noncardiac surgeries.12358
What is the purpose of this trial?
A multicenter, interventional, feasibility comparison with historical controls
Research Team
Tina Abdelnour, MS, BSN
Principal Investigator
Edwards Lifesciences
Eligibility Criteria
The SMART TRENDS Study is for adults over 18 who are undergoing elective noncardiac surgery expected to last at least 3 hours with a post-op hospital stay of at least 3 days. Participants must be monitored with an arterial catheter under general anesthesia. Those with planned vasopressor use, contraindications to arterial monitoring, severe kidney issues, or on mechanical support can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo intra-operative hemodynamic management using Acumen HPI Smart Alerts and Smart Trends during non-cardiac surgery
Follow-up
Participants are monitored for renal injury and compliance with hemodynamic management post-surgery
Treatment Details
Interventions
- Acumen HPI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD