Clinical trial NCT05779683: Caretaker in the Cardiovascular Intensive Care Unit (CVICU)
Official title: Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Hemodynamic Monitoring
Keywords: cardiopulmonary bypass
Blood Pressure (BP) monitoring
Pulmonary Artery (PA) catheters
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p CABG, valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)

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.

Eligibility criteria: Inclusion:

* Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p Coronary artery bypass graft surgery (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
* patients (age \> 18) admitted to the Intensive Care Unit (ICU)
* Pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure monitoring (standard of care)

Exclusion:

* Patients without an appropriately positioned or functioning PA catheter admitted to the cardiac surgery ICU after surgery
* Patients on left ventricular assist device (LVAD) support

Primary outcomes:
measure: Comparison of hemodynamic readings between the Caretaker and the PAC
timeFrame: 24 hours
measure: Number of Periods of Carbon monoxide (CO) Instability
timeFrame: 24 hours
measure: Time Spent in Periods of CO Instability
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashish Khanna, MD
role: PRINCIPAL_INVESTIGATOR
References: