NCT05779683

Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Type	Name	Description
DEVICE	Caretaker Device placement	placement of the device on the postoperative cardiac surgery patient that has a pulmonary artery catheter for comparison readings

Timeline

• Start date: 2021-11-01
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2023-03-22
• Last updated: 2023-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study