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 (SpO(2)) 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 SpO(2) 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 SpO(2) 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.