TY - JOUR
T1 - Performance of a novel reusable pediatric pulse oximeter probe
AU - King, Carina
AU - Mvalo, Tisungane
AU - Sessions, Kristen
AU - Wilson, Iain
AU - Walker, Isabeau
AU - Zadutsa, Beatiwel
AU - Makwenda, Charles
AU - Phiri, Tambosi
AU - Boyd, Nicholas
AU - Bernstein, Mike
AU - McCollum, Eric D.
N1 - Funding Information:
We would like to thank all the caregivers and children who took part in the testing for their time and co-operation, along with the staff at Kamuzu Central Hospital, Bwaila Hospital, and Mchinji District Hospital for their support in this study. We would like to acknowledge Laura Ruegsegger and Innocent Ndindi (UNC Project Malawi) for data collection in the cross-over study, and the remaining members of The Lifebox Study group: Dr Tim Colbourn and Dr Bejoy Nambiar (University College London); Ms Katie Fernandez (the Lifebox Foundation). The historical usability testing was funded by the Bill and Melinda Gates Foundation (OPP1133291). The cross-over equivalence testing was not supported by a specific project grant. Kristen Session received salary support from the Doris Duke Charitable Foundation. Eric D McCollum received support from the National Institutes of Health through the Fogarty International Center (K01TW009988).
Funding Information:
We would like to thank all the caregivers and children who took part in the testing for their time and co‐operation, along with the staff at Kamuzu Central Hospital, Bwaila Hospital, and Mchinji District Hospital for their support in this study. We would like to acknowledge Laura Ruegsegger and Innocent Ndindi (UNC Project Malawi) for data collection in the cross‐over study, and the remaining members of The Lifebox Study group: Dr Tim Colbourn and Dr Bejoy Nambiar (University College London); Ms Katie Fernandez (the Lifebox Foundation). The historical usability testing was funded by the Bill and Melinda Gates Foundation (OPP1133291). The cross‐ over equivalence testing was not supported by a specific project grant. Kristen Session received salary support from the Doris Duke Charitable Foundation. Eric D McCollum received support from the National Institutes of Health through the Fogarty International Center (K01TW009988).
Publisher Copyright:
© 2019 The Authors. Pediatric Pulmonology Published by Wiley Periodicals, Inc.
PY - 2019/7
Y1 - 2019/7
N2 - 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.
AB - 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.
KW - LMIC
KW - hypoxemia
KW - pediatric
KW - pulse oximeter
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U2 - 10.1002/ppul.24295
DO - 10.1002/ppul.24295
M3 - Article
C2 - 30912314
AN - SCOPUS:85063589893
SN - 8755-6863
VL - 54
SP - 1052
EP - 1059
JO - Pediatric pulmonology
JF - Pediatric pulmonology
IS - 7
ER -