Performance of the new SmartCardia wireless, wearable oximeter: a comparison with arterial SaO2 in healthy volunteers

F. Rincon, J. Pidoux, S. Murali & J.J. Goy, BMC Anesthesiology volume 22, Article number: 77 (2022)

Background

Our goal was to evaluate the performance of a new wearable arm located pulse oximeter.

Methods

Twelve volunteers were monitored with three pulse oximeters and underwent desaturation to 70% SaO₂.

We compared the accuracy of SpO₂ reading from the SmartCardia system with SpO₂ using two well established devices (Masimo and Nellcor) as reference.

Oximetry was performed at different level of oxygen saturation varying from 70 to 100%. Bias, ARMS and precision were evaluated using Bland-Altman plots.

Results

The mean (SD) differences between SaO₂ compared to SpO₂ and the devices were as follows: SaO₂ versus Masimo 2,12 ± 1,01% (95% CI 1,45 to 2,79), SaO₂ versus Nellcor 0,78 ± 0,58% (95% CI − 0,29 to 1,65) and SaO₂ versus SmartCardia 0,42 ± 0,24% (95% CI − 0,64 to 1,46). The bias between SmartCardia, Masimo, Nellcor devices and SaO₂ was 0.16 (95% CI 0.05 to 0.33) and LoA (level of agreements) 2.96 (95% CI − 2,68 to 2,89) for SmartCardia, 2,02 (95% CI 1,49 to 2,54) and LoA − 6 to 11 for Masimo, and 0,76 (95% CI 0,5 to − 1) and LoA − 3,5 to 5,0 for Nellcor. ARMS for the 70–100% SaO₂ range was 1,4 for SmartCardia, 5,0 for Masimo and 2,31 for Nellcor.

Conclusions

The new wireless SmartCardia SpO₂ measurement system demonstrated in-line results, bias, ARMS and precision in healthy volunteers, when compared with the gold standard SaO2 and with two well established systems, Masimo and Nellcor.

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