Abstract
BackgroundChanges in oxygen saturation (SpO2) exposure have been shown to have a marked impact on neonatal outcomes and therefore careful titration of inspired oxygen is essential. In routine use, however, the frequency of SpO2 alarms not requiring intervention results in alarm fatigue and its corresponding risk. SpO2 control systems that automate oxygen adjustments (Auto-FiO2) have been shown to be safe and effective. We speculated that when using Auto-FiO2, alarm settings could be refined to reduce unnecessary alarms, without compromising safety.MethodsAn unblinded randomized crossover study was conducted in a single NICU among infants routinely managed with Auto-FiO2. During the first 6 days of respiratory support a tight and a loose alarm strategy were switched each 24 h. A balanced block randomization was used. The tight strategy set the alarms at the prescribed SpO2 target range, with a 30-s delay. The loose strategy set the alarms 2 wider, with a 90-s delay. The effectiveness outcome was the frequency of SpO2 alarms, and the safety outcomes were time at SpO2 extremes (< 80, > 98%). We hypothesized that the loose strategy would result in a marked decrease in the frequency of SpO2 alarms, and no increases at SpO2 extremes with 20 subjects. Within subject differences between alarm strategies for the primary outcomes were evaluated with Wilcoxon signed-rank test.ResultsDuring a 13-month period 26 neonates were randomized. The analysis included 21 subjects with 49 days of both tight and loose intervention. The loose alarm strategy resulted in a reduction in the median rate of SpO2 alarms from 5.2 to 1.6 per hour (p < 0.001, 95%-CI difference 1.6–3.7). The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0–0.2%).ConclusionsIn this group of infants we found a marked advantage of the looser alarm strategy. We conclude that the paradigms of alarm strategies used for manual titration of oxygen need to be reconsidered when using Auto-FiO2. We speculate that with optimal settings false positive SpO2 alarms can be minimized, with better vigilance of clinically relevant alarms.Trial registrationRetrospectively registered 15 May 2018 at ISRCTN (49239883).
Highlights
Changes in oxygen saturation (SpO2) exposure have been shown to have a marked impact on neonatal outcomes and careful titration of inspired oxygen is essential
Pulse oximetry (SpO2) is the standard of care for monitoring oxygenation in the Neonatal intensive care unit (NICU). [1, 2] Changes in Arterial oxygen saturation measured noninvasively (SpO2) exposure, extremes associated with hypoxemia and hyperoxemia are associated with marked changes in morbidity and mortality
It is considered a major hazard in the ICU. [7, 8] While selection of proper SpO2 alarm settings has been proposed as a mitigating solution [8,9,10] to excess alarms, this is a trade-off
Summary
This was a single center study, conducted at the Independent Public Clinical Hospital of Prof W. The system is capable of noninvasive support and was used sometimes when infants were transitioning from intubation, and later in their course of treatment, in the case of exacerbation and prevalent desaturations This was a crossover study of two alarm strategies, tight and loose. The primary safety outcomes were the prevalence (percent time) at extreme SpO2 levels We defined these as hyperoxemia (SpO2 > 98% with FiO2 > 21%) and hypoxemia (SpO2 < 80%). More inclusive of the variation in the actual set SpO2 control ranges It was reported both as normoxemia which included time when SpO2 > 96% with a FiO2 of 0.21, and only during periods of supplemental oxygenation. Effect sizes of the primary outcomes were described with 95% confidence intervals of the median difference
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