MedTrace Logo

Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

NCT05779683 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-22

No results posted yet for this study

Summary

To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject. This device also does not project energy into the subject.

Conditions

  • Cardiac Output
  • Hemodynamic Monitoring

Interventions

DEVICE

Caretaker Device placement

placement of the device on the postoperative cardiac surgery patient that has a pulmonary artery catheter for comparison readings

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Ashish Khanna, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2021-12-28
Completion
2021-12-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779683 on ClinicalTrials.gov