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Agreement between cardiac output estimation with a wireless, wearable pulse decomposition analysis device and continuous thermodilution in post cardiac surgery intensive care unit patients

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Abstract

Purpose

Pulse Decomposition Analysis (PDA) uses integration of the systolic area of a distally transmitted aortic pulse as well as arterial stiffness estimates to compute cardiac output. We sought to assess agreement of cardiac output (CO) estimation between continuous pulmonary artery catheter (PAC) guided thermodilution (CO-CCO) and a wireless, wearable noninvasive device, (Vitalstream, Caretaker Medical, Charlottesville, VA), that utilizes the Pulse Decomposition Analysis (CO-PDA) method in postoperative cardiac surgery patients in the intensive care unit.

Methods

CO-CCO measurements were compared with post processed CO-PDA measurements in prospectively enrolled adult cardiac surgical intensive care unit patients. Uncalibrated CO-PDA values were compared for accuracy with CO-CCO via a Bland-Altman analysis considering repeated measurements and a concordance analysis with a 10% exclusion zone.

Results

259.7 h of monitoring data from 41 patients matching 15,583 data points were analyzed. Mean CO-CCO was 5.55 L/min, while mean values for the CO-PDA were 5.73 L/min (mean of differences +- SD 0.79 ± 1.11 L/min; limits of agreement − 1.43 to 3.01 L/min), with a percentage error of 37.5%. CO-CCO correlation with CO-PDA was moderate (0.54) and concordance was 0.83.

Conclusion

Compared with the CO-CCO Swan-Ganz, cardiac output measurements obtained using the CO-PDA were not interchangeable when using a 30% threshold. These preliminary results were within the 45% limits for minimally invasive devices, and pending further robust trials, the CO-PDA offers a noninvasive, wireless solution to complement and extend hemodynamic monitoring within and outside the ICU.

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Abbreviations

ICU:

Intensive care unit

BMI:

Body mass index

AKI:

Acute kidney injury

KDIGO:

Kidney Disease: Improving Global Outcomes

SD:

Standard Deviation

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Acknowledgements

None.

Funding

This study was funded by Caretaker Medical, Charlottesville, VA.

Author information

Authors and Affiliations

  1. Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC, USA

    Ashish K. Khanna

  2. Outcomes Research Consortium, Cleveland, OH, USA

    Ashish K. Khanna

  3. Perioperative Outcomes and Informatics Collaborative (POIC), Winston-Salem, NC, USA

    Ashish K. Khanna, Amit K Saha & Lynnette Harris

  4. Wake Forest University School of Medicine, Winston-Salem, NC, USA

    Julio O Garcia

  5. Department of Anesthesiology, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC, USA

    Amit K Saha & Lynnette Harris

  6. Caretaker Medical, Charlottesville, VA, USA

    Martin Baruch

  7. Department of Surgery, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, NC, USA

    R. Shayn Martin

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Contributions

AKK: Investigation, Conceptualization, Writing - Review & Editing; JG: Data Collection, Writing – Editing AS: Data Collection, Writing – Editing; MB: Data Analysis, Writing – Editing LH: Data Collection, Writing – Editing RSM: Data Collection, Writing – Editing. All authors reviewed the manuscript.

Corresponding author

Correspondence to Ashish K. Khanna.

Ethics declarations

Ethics approval and consent to participate

This research meets the criteria for a waiver of consent entirely according to 45 CFR 46(d).

Informed Consent

Wake Forest University School of Medicine?s IRB granted a waiver of consent for this study.

Competing interests

MB is an employee at Caretaker Medical the manufacturer of the Vitalstream monitor. AKK consults for Medtronic, Edwards Life Sciences, Philips Research North America, GE Healthcare, Potrero Medical, Retia Medical and Caretaker Medical. He is also funded with a Clinical and Translational Science Institute (CTSI) NIH/NCTAS KL2 TR001421 award for a trial on continuous postoperative hemodynamic and saturation monitoring. The department of anesthesiology is supported by Edwards Lifesciences under a master clinical trials agreement. He is a founding member of the BrainX group.

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Khanna, A.K., Garcia, J.O., Saha, A.K. et al. Agreement between cardiac output estimation with a wireless, wearable pulse decomposition analysis device and continuous thermodilution in post cardiac surgery intensive care unit patients. J Clin Monit Comput 38, 139–146 (2024). https://doi.org/10.1007/s10877-023-01059-5

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