Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

NCT05779683 | Completed FDA Device

• 1 other identifier: IRB00074289
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Output; Hemodynamic Monitoring

Keywords

cardiopulmonary bypass; Blood Pressure (BP) monitoring; Pulmonary Artery (PA) catheters

Outcome Measures

Primary Outcomes (3)

• Comparison of hemodynamic readings between the Caretaker and the PAC

  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.

  24 hours

• Number of Periods of Carbon monoxide (CO) Instability

  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

  24 hours

• Time Spent in Periods of CO Instability

  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.

  24 hours

Study Arms (1)

Caretaker device in CVICU patient

device placed on the subject after arrival to the cardiac intensive care unit postoperatively

Device: Caretaker Device placement

Interventions

Caretaker Device placement DEVICE

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

Caretaker device in CVICU patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Ashish Khanna, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: November 1, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: March 22, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)