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Completed

NCT Number: NCT05779683

Caretaker in the Cardiovascular Intensive Care Unit (CVICU)

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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Key information

Conditions

Cardiac Output Hemodynamic Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caretaker Device placement

Device

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

Primary outcomes

  1. Comparison of hemodynamic readings between the Caretaker and the PAC

    Time frame: 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.

  2. Number of Periods of Carbon monoxide (CO) Instability

    Time frame: 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

  3. Time Spent in Periods of CO Instability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2023
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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