Impact of Study Oximeter Masking Algorithm on Titration of Oxygen Therapy in the Canadian Oxygen Trial - 23/09/14

, Robin S. Roberts, MSc 2, Robin K. Whyte, MB 3, Elizabeth V. Asztalos, MD 4, Christian Poets, MD 5, Yacov Rabi, MD 6, Alfonso Solimano, MD 7, Harvey Nelson, MSc 2for the
Canadian Oxygen Trial Group∗
Abstract |
Objective |
To compare oxygen saturations as displayed to caregivers on offset pulse oximeters in the 2 groups of the Canadian Oxygen Trial.
Study design |
In 5 double-blind randomized trials of oxygen saturation targeting, displayed saturations between 88% and 92% were offset by 3% above or below the true values but returned to true values below 84% and above 96%. During the transition, displayed values remained static at 96% in the lower and at 84% in the higher target group during a 3% change in true saturations. In contrast, displayed values changed rapidly from 88% to 84% in the lower and from 92% to 96% in the higher target group during a 1% change in true saturations. We plotted the distributions of median displayed saturations on days with >12 hours of supplemental oxygen in 1075 Canadian Oxygen Trial participants to reconstruct what caregivers observed at the bedside.
Results |
The oximeter masking algorithm was associated with an increase in both stability and instability of displayed saturations that occurred during the transition between offset and true displayed values at opposite ends of the 2 target ranges. Caregivers maintained saturations at lower displayed values in the higher than in the lower target group. This differential management reduced the separation between the median true saturations in the 2 groups by approximately 3.5%.
Conclusions |
The design of the oximeter masking algorithm may have contributed to the smaller-than-expected separation between true saturations in the 2 study groups of recent saturation targeting trials in extremely preterm infants.
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Plan
| Funded by the Canadian Institutes of Health Research (MCT-79217). Y.R. has a patent in the US and Japan, as well as a patent pending in the European Union, for a technology that integrates with pulse oximeters to help guide oxygen use in the delivery room (revenues will be shared with his university and health region); he has received royalties from Masimo Corporation in relation to the patent and commercialization of the technology. A member of C.P.'s division, who was not involved in this study, received pulse oximeters for a different research study from Masimo, Inc (Irvine, CA) free of charge. Neither the funding agency nor Masimo Corporation had any role in the design and conduct of the study; in the collection, analysis and interpretation of the data; or in the preparation, review, or approval of the manuscript. The other authors declare no conflicts of interest. |
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| Registered with ISRCTN.org (ISRCTN 62491227) and ClinicalTrials.gov (NCT00637169). |
Vol 165 - N° 4
P. 666 - octobre 2014 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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