Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

Completed

• Conditions: Hemodynamic Monitoring; Cardiac Output
• Interventions: Device: Caretaker Device placement

• Registration Number: NCT05779683
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Status Verified: 2022-06
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caretaker device in CVICU patient	Caretaker Device placement	device placed on the subject after arrival to the cardiac intensive care unit postoperatively

Primary Outcome Measures

Name	Time	Method
Number of Periods of Carbon monoxide (CO) Instability	24 hours	The incidence of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care
Comparison of hemodynamic readings between the Caretaker and the PAC	24 hours	To assess the agreement of the Caretaker monitor CO with the thermodilution method using the swan-ganz or pulmonary artery (PAC) catheter in critically ill cardiac surgery post-op ICU patients.
Time Spent in Periods of CO Instability	24 hours	The time spent during periods of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care.

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States