Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

A multicenter, interventional, feasibility comparison with historical controls

Official Title

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.

Keywords

Moderate to High-risk Noncardiac Surgery, Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UC Davis Medical Center in progress, not accepting new patients
    Sacramento California 95817 United States
  • Oregon Health & Science University in progress, not accepting new patients
    Portland Oregon 997239 United States
  • Henry Ford Health System accepting new patients
    Detroit Michigan 48202 United States
  • Prisma Health accepting new patients
    Greenville South Carolina 29615 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT05957406
Study Type
Interventional
Participants
Expecting 244 study participants
Last Updated