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The trial is taking place at:
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Prisma Health | Upstate Greenville Memorial Cardiac Research

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SMART TRENDS Study

Edwards Lifesciences logo

Edwards Lifesciences

Status

Active, not recruiting

Conditions

Moderate to High-risk Noncardiac Surgery

Treatments

Device: Acumen HPI Smart Alerts and Smart Trends Software

Study type

Interventional

Funder types

Industry

Identifiers

NCT05957406
2023-05

Details and patient eligibility

About

A multicenter, interventional, feasibility comparison with historical controls

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

153 participants in 1 patient group

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

Trial contacts and locations

8

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Central trial contact

Cristina Johnson

Data sourced from clinicaltrials.gov

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