Performance of a novel reusable pediatric pulse oximeter probe

Objective: To assess the performance of reusable pulse oximeter probe and microprocessor box combinations, of varying price-points, in the context of a low-income pediatric setting. Methods: A prospective, randomized cross-over study comparing time to biologically plausible oxygen saturation (SpO2) between: (1) Lifebox LB-01 probe with Masimo Rad-87 box (L + M) and (2) a weight-appropriate reusable Masimo probe with Masimo Rad-87 box (M + M). A post hoc secondary analysis comparison with historical usability testing data with the Lifebox LB-01 probe and Lifebox V1.5 box (L + L) was also conducted. Participants, children aged 0 to 35 months, were recruited from pediatric wards and outpatient clinics in the central region of Malawi. The primary outcome was time taken to achieve a biologically plausible SpO 2 measurement, compared using t tests for equivalence. Results: We recruited 572 children. Plausible SpO2 measurements were obtained in less than 1 minute, 71%, 70%, and 63% for the M + M, L + M, and L + L combinations, respectively. A similar pattern was seen for less than 2 minutes, however, this effect disappeared at less than 5 minutes with 96%, 96%, and 95% plausible measurements. Using a ±10 second threshold for equivalence, we found L + M and M + M to be equivalent, but were under-powered to assess equivalence for L + L. Conclusions: The novel reusable pediatric Lifebox probe can achieve a quality SpO2 measurement within a pragmatic time range of weight-appropriate Masimo equivalent probes. Further research, which considers the cost of the devices, is needed to assess the added value of sophisticated motion tolerance software.