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Device

AcumenTM HPI Software Feature for Noncardiac Surgery

N/A
Waitlist Available
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post non-cardiac surgery to 30 days.
Awards & highlights

Study Summary

This trial looked at whether a protocolized strategy using Hypotension Prediction Index (HPI) software guidance during surgery could help manage intraoperative hemodynamic better in moderate to high-risk surgeries.

Eligible Conditions
  • Moderate to High-risk Noncardiac Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from post non-cardiac surgery to 30 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from post non-cardiac surgery to 30 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HPI ArmExperimental Treatment1 Intervention
AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Group II: Non-HPI armPlacebo Group1 Intervention
Non-protocolized standard of care management per clinician and provider judgement

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Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,983 Total Patients Enrolled
~116 spots leftby Jun 2025
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