Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2021-12-28

Brief Summary

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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.

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Detailed Description

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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

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Cardiac Output Hemodynamic Monitoring

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Caretaker device in CVICU patient

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

Caretaker Device placement

Intervention Type DEVICE

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

Interventions

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Caretaker Device placement

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No