COMPLETED

SMART TRENDS Study

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Conditions

Moderate to High-risk Noncardiac Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Quick Facts

Study Start:2023-07-11
Study Completion:2025-10-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05957406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent
  2. * Age ≥ 18 years
  3. * ASA Physical Status ≥ 2
  4. * Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
  5. * Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
  6. * General anesthesia with tracheal intubation and positive pressure ventilation
  1. * 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
  2. * Planned vasopressor or inotrope infusion during surgery
  3. * Contraindication to intra-arterial blood pressure monitoring
  4. * Has previously participated in the SMART TRENDS study
  5. * Serum creatine \> 2.0 mg/dL (\> 175 μmol/L) or CKD stage \> 3A
  6. * Scheduled for intracranial or cardiac surgery
  7. * Patient who is known to be pregnant
  8. * Patients on mechanical circulatory support
  9. * Emergency surgery
  10. * Planned beach-chair positioning
  11. * 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
  12. * Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
  13. * Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)

Contacts and Locations

Study Locations (Sites)

UC Davis Medical Center
Sacramento, California, 95817
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Duke University
Durham, North Carolina, 27705
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Oregon Health & Science University
Portland, Oregon, 997239
United States
Prisma Health
Greenville, South Carolina, 29615
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11
Study Completion Date2025-10-27

Study Record Updates

Study Start Date2023-07-11
Study Completion Date2025-10-27

Terms related to this study

Additional Relevant MeSH Terms

  • Moderate to High-risk Noncardiac Surgery