Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05779683
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2023-03-09
Brief Title:
Caretaker in the Cardiovascular Intensive Care Unit CVICU
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 monitors 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 monitors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None