Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Cleveland, Ohio and other locations
Dates
study started
estimated completion

Description

Summary

A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.

Official Title

Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)

Keywords

Moderate to High-risk Noncardiac Surgery, Hypotension, AcumenTM HPI Software Feature

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Signed informed consent
  2. Age >18 years
  3. ASA Physical Status > 2
  4. Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
  5. Planned blood pressure monitoring with an arterial line catheter;
  6. General anesthesia;

You CAN'T join if...

  1. Participating in another interventional Trial;
  2. Contraindication to arterial blood pressure monitoring;
  3. Subjects with a physical site area too limited for proper Sensor placement
  4. Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
  5. Scheduled for intracranial surgery with permissive hypotension;
  6. Patient who is confirmed to be pregnant and/or nursing mothers;
  7. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
  8. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
  9. Emergency surgery;
  10. . Require beach-chair positioning;
  11. . Scheduled for cardiac surgeries
  12. . Have previously participated in the SMART-BP trial.

Locations

  • Cleveland Clinic accepting new patients
    Cleveland Ohio 97239 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 997239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
Links
Sign up for this study
ID
NCT05105477
Study Type
Interventional
Participants
Expecting 1486 study participants
Last Updated