76 Chapter 4 Time within SpO2 ranges In the primary analysis where episodes of room air were excluded, infants in the OxyGenie epoch spent 71.5 [64.6 – 77.0] % of the time within target range of 91%- 95% versus 51.3 [47.3 – 58.5] % in the CLiO2 epoch (p < 0.001, Table 3). This was mainly attributable to less time above the target range in the OxyGenie epoch (OxyGenie 11.5 [8.7 – 15.8] %, CLiO2 23.9 [16.3 – 32.1] %, p < 0.001), and to a lesser extent to a reduction in time under the target range (OxyGenie 16.1 [12.6 – 19.2], CLiO2 22.0 [18.2 – 26.0], p < 0.001). Oxygen saturations under 80% were measured 0.7 [0.4 – 1.4] % of the time with OxyGenie and 1.2 [0.7 – 2.3] % of the time with CLiO2 (p < 0.001); oxygen saturations above 98% were measured 1.0 [0.5 – 2.4] % of the time with OxyGenie and 4.0 [2.0 – 7.9] % of the time with CLiO2 (p < 0.001). The average FiO2 was not significantly different. Table 3. Recordings >72 hours while supplemental oxygen administered, excluding episodes in room air Outcome Oxygenie N=75 CLiO2 N=111 p value* Time SpO2 in target range† % 71.5 [64.6 – 77.0] 51.3 [47.3 – 58.5] <0.001 Time SpO2 < target range % 16.1 [12.6 – 19.2] 22.0 [18.2 – 26.0] <0.001 Time SpO2 > target range % 11.5 [8.7 – 15.8] 23.9 [16.3 – 32.1] <0.001 SpO2 85% - 89% % 8.3 [6.5 – 9.9] 11.6 [9.5 – 14.1] <0.001 SpO2 80% - 84% % 1.7 [1.0 – 2.3] 2.9 [1.8 – 3.8] <0.001 SpO2 < 80% % 0.7 [0.4 – 1.4] 1.2 [0.7 – 2.3] <0.001 SpO2 96% - 98% % 10.5 [7.7 – 13.7] 19.3 [14.3 – 24.1] <0.001 SpO2 > 98% % 1.0 [0.5 – 2.4] 4.0 [2.0 – 7.9] <0.001 Average FiO2§ % 29.5 [28.0 – 33.2] 29.6 [27.7 – 32.1] n.s. Data in median [IQR]; * Kruskal-Wallis test; † 91% <= SpO2 <= 95%; § Average FiO 2 is based on measured FiO2 for OxyGenie and on intended/set FiO2 for CLiO2 In figure 1A, 1C and 1D the average proportion of time within the SpO2 different ranges (SpO2 91-95%, SpO2 <80%, SpO2 >98% respectively) can be viewed per day since birth, which shows a decline in proportion with increasing age. When set against the postmenstrual age this decline is less apparent in the OxyGenie group (Figure 1B). The average FiO2 excluding room air (Figure 2) has a similar course for both epochs, although around the age of 30 days and 50 days there are fewer infants contributing to the data leading to a higher standard deviation and differences between controllers.
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