OBJECTIVE: To evaluate the effect of implementing automated oxygen control as routine care in maintaining oxygen saturation (SpO2) within target range in preterm infants. METHODS: Infants <30 weeks gestation in Leiden University Medical Centre before and after the implementation of automated oxygen control were compared. The percentage of time spent with SpO2 within and outside the target range (90-95%) was calculated. SpO2 values were collected every minute and included for analysis when infants received extra oxygen. RESULTS: In a period of 9 months, 42 preterm infants (21 manual, 21 automated) were studied. In the automated period, the median (IQR) time spent with SpO2 within target range increased (manual vs automated: 48.4 (41.5-56.4)% vs 61.9 (48.5-72.3)%; p<0.01) and time SpO2 >95% decreased (41.9 (30.6-49.4)% vs 19.3 (11.5-24.5)%; p<0.001). The time SpO2<90% increased (8.6 (7.2-11.7)% vs 15.1 (14.0-21.1)%; p<0.0001), while SpO2<80% was similar (1.1 (0.4-1.7)% vs 0.9 (0.5-2.1)%; ns). CONCLUSIONS: During oxygen therapy, preterm infants spent more time within the SpO2 target range after implementation of automated oxygen control, with a significant reduction in hyperoxaemia, but not hypoxaemia.

• MeSH
• intratracheální intubace MeSH
• jednotky intenzivní péče o novorozence MeSH
• kyslík aplikace a dávkování   krev   MeSH
• lidé MeSH
• monitorování fyziologických funkcí * MeSH
• neinvazivní ventilace MeSH
• novorozenec nedonošený MeSH
• novorozenec MeSH
• oxygenoterapie MeSH
• oxymetrie * MeSH
• prospektivní studie MeSH
• Check Tag
• lidé MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH

Manual titration of inspired oxygen necessary to adequately respond to respiratory fluctuations of the neonate is a challenging task. Furthermore exposure to high and low levels of oxygen saturations are associated with significant morbidity and mortality. Ventilators that automatically control inspired oxygen based on pulse oximeter signals are becoming available, and seem to be safe and effective when compared to manual control. However the potential to overshoot in response to a hypoxemic episode, thus causing excess hyperoxemia, has not been carefully studied. We evaluated the response of one automated FiO2-SpO2control system to 9,486 desaturations in 21 infants over 113 days. We found that the sustained response to desaturations resulted primarily in achievement of normoxemia with balance between high and low saturations. We concluded that this closed loop control system was adequately damped. We suggest that this kind of analysis might be helpful is refining control algorithms.

• MeSH
• hypoxie prevence a kontrola   MeSH
• intenzivní péče o novorozence MeSH
• kyslík terapeutické užití   MeSH
• lidé MeSH
• mechanické ventilátory * MeSH
• novorozenec nedonošený MeSH
• ošetřovatelství novorozenců MeSH
• oxygenoterapie * metody   MeSH
• porodní hmotnost MeSH
• spotřeba kyslíku MeSH
• Check Tag
• lidé MeSH

OBJECTIVE: To determine the efficacy and safety of automated adjustment of the fraction of inspired oxygen (FiO2) in maintaining arterial oxygen saturation (SpO2) within a higher (91%-95%) and a lower (89%-93%) target range in preterm infants. STUDY DESIGN: Eighty preterm infants (gestational age [median]: 26 weeks, age [median] 18 days) on noninvasive (n = 50) and invasive (n = 30) respiratory support with supplemental oxygen, were first randomized to one of the SpO2 target ranges and then treated with automated FiO2 (A-FiO2) and manual FiO2 (M-FiO2) oxygen control for 24 hours each, in random sequence. RESULTS: The percent time within the target range was higher during A-FiO2 compared with M-FiO2 control. This effect was more pronounced in the lower SpO2 target range (62 ± 17% vs 54 ± 16%, P < .001) than in the higher SpO2 target range (62 ± 17% vs 58 ± 15%, P < .001). The percent time spent below the target or in hypoxemia (SpO2 <80%) was consistently reduced during A-FiO2, independent of the target range. The time spent above the target range or at extreme hyperoxemia (SpO2 >98%) was only reduced during A-FiO2 when targeting the lower SpO2 range (89%-93%). These outcomes did not differ between infants on noninvasive and invasive respiratory support. Manual adjustments were significantly reduced during A-FiO2 control. CONCLUSIONS: A-FiO2 control improved SpO2 targeting across different SpO2 ranges and reduced hypoxemia in preterm infants on noninvasive and invasive respiratory support. TRIAL REGISTRATION: ISRCTN 56626482.

• MeSH
• jednotky intenzivní péče o novorozence MeSH
• klinické křížové studie MeSH
• kyslík krev   terapeutické užití   MeSH
• lidé MeSH
• novorozenec nedonošený MeSH
• novorozenec MeSH
• oxymetrie metody   MeSH
• umělé dýchání metody   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa MeSH
• Kanada MeSH

Oxygen is the most common drug used in the neonatal intensive care. It has a narrow therapeutic range in preterm infants. Too high (hyperoxemia) or low oxygen (hypoxemia) is associated with adverse neonatal outcomes. It is not only prudent to maintain oxygen saturations in the target range, but also to avoid extremes of oxygen saturations. In routine practice when done manually by the staff, it is challenging to maintain oxygen saturations within the target range. Automatic control of oxygen delivery is now feasible and has shown to improve the time spent with in the target range of oxygen saturations. In addition, it also helps to avoid extremes of oxygen saturation. However, there are no studies that evaluated the clinical outcomes with automatic control of oxygen delivery. In this narrative review article, we aim to present the current evidence on automatic oxygen control and the future directions.

• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

BACKGROUND: Changes 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. METHODS: An 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. RESULTS: During 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%). CONCLUSIONS: In 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 REGISTRATION: Retrospectively registered 15 May 2018 at ISRCTN ( 49239883 ).

• MeSH
• automatizace MeSH
• hypoxie prevence a kontrola   MeSH
• jednotky intenzivní péče o novorozence MeSH
• klinické alarmy * MeSH
• klinické křížové studie MeSH
• lidé MeSH
• monitorování fyziologických funkcí MeSH
• nemocnice veřejné MeSH
• novorozenec nedonošený * MeSH
• novorozenec MeSH
• oxygenoterapie metody   MeSH
• oxymetrie MeSH
• péče o pacienty v kritickém stavu metody   MeSH
• prognóza MeSH
• spotřeba kyslíku fyziologie   MeSH
• umělé dýchání metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Polsko MeSH

• MeSH
• biodegradace MeSH
• financování organizované MeSH
• kyslík analýza   MeSH
• monitorování životního prostředí metody   přístrojové vybavení   MeSH
• oxid uhličitý analýza   MeSH

OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

• MeSH
• hyperoxie prevence a kontrola   MeSH
• hypoxie MeSH
• jednotky intenzivní péče o novorozence * MeSH
• klinické křížové studie * MeSH
• kyslík krev   aplikace a dávkování   MeSH
• lidé MeSH
• novorozenec nedonošený MeSH
• novorozenec MeSH
• oxygenoterapie metody   škodlivé účinky   přístrojové vybavení   MeSH
• oxymetrie metody   MeSH
• saturace kyslíkem * MeSH
• umělé dýchání škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pragmatická klinická studie MeSH
• randomizované kontrolované studie MeSH

The introduction and adoption of new technology in medicine is a continuous ever present process but it is often not studied. Insights gained from documenting such experiences can not only guide local practices but also provide valuable quality benchmarks. Automated control of FiO2 based on continuous SpO2 (A-FiO2) not only reduces the challenging task of manual oxygen titration, but also has the potential to greatly improve the morbidity and mortality of extremely preterm infants. First approved for use in Europe in 2012, it is now available on most infant ventilators outside the USA. Poland was the first region in Europe to implement its clinical use. We report experience from 619 infants from 12 centers recorded in a web-based registry established in 2013 to document its use. We found the A-FiO2 was primarily used in the first week of life in intubated infants. However it is also successfully applied in both noninvasively supported infants and in those who were difficult to wean from oxygen and who exhibited frequent desaturations. We also found the SpO2 target range and alarm setting are not different from normal manual titration, although wider settings are also used and promise some benefit. Finally we report our plan to gather data from a national data base and detailed surveys. The surveys will document subjective aspects of this experience from a core group of centers. Details of the surveys are included and cover: experience with training and acceptance, changes in practice associated with the years of experience and barriers to broader use.

• MeSH
• jednotky intenzivní péče o novorozence * MeSH
• lidé MeSH
• mechanické ventilátory * MeSH
• monitorování fyziologických funkcí * MeSH
• novorozenec nedonošený MeSH
• novorozenec MeSH
• oxygenoterapie * metody   přístrojové vybavení   MeSH
• oxymetrie * metody   přístrojové vybavení   MeSH
• retrospektivní studie MeSH
• syndrom respirační tísně novorozenců * terapie   MeSH
• trvalý přetlak v dýchacích cestách metody   přístrojové vybavení   MeSH
• umělé dýchání * metody   MeSH
• ventilace umělá s výdechovým přetlakem metody   přístrojové vybavení   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• novorozenec MeSH
• ženské pohlaví MeSH
• Geografické názvy
• Polsko MeSH

OBJECTIVE: This randomised study in preterm infants on non-invasive respiratory support investigated the effectiveness of automated oxygen control (A-FiO2) in keeping the oxygen saturation (SpO2) within a target range (TR) during a 28-day period compared with manual titration (M-FiO2). DESIGN: A single-centre randomised control trial. SETTING: A level III neonatal intensive care unit. PATIENTS: Preterm infants (<28 weeks' gestation) on non-invasive respiratory support. INTERVENTIONS: A-FiO2 versus M-FiO2 control. METHODS: Main outcomes were the proportion of time spent and median area of episodes in the TR, hyperoxaemia, hypoxaemia and the trend over 28 days using a linear random intercept model. RESULTS: 23 preterm infants (median gestation 25.7 weeks; birth weight 820 g) were randomised. Compared with M-FiO2, the time spent within TR was higher in the A-FiO2 group (68.7% vs 48.0%, p<0.001). Infants in the A-FiO2 group spent less time in hyperoxaemia (13.8% vs 37.7%, p<0.001), but no difference was found in hypoxaemia. The time-based analyses showed that the A-FiO2 efficacy may differ over time, especially for hypoxaemia. Compared with the M-FiO2 group, the A-FiO2 group had a larger intercept but with an inversed slope for the daily median area below the TR (intercept 70.1 vs 36.3; estimate/day -0.70 vs 0.69, p<0.001). CONCLUSION: A-FiO2 control was superior to manual control in keeping preterm infants on non-invasive respiratory support in a prespecified TR over a period of 28 days. This improvement may come at the expense of increased time below the TR in the first days after initiating A-FiO2 control. TRIAL REGISTRATION NUMBER: NTR6731.

• MeSH
• hypoxie prevence a kontrola   MeSH
• klinické křížové studie MeSH
• kojenec MeSH
• kyslík * MeSH
• lidé MeSH
• novorozenec nedonošený * MeSH
• novorozenec MeSH
• porodní hmotnost MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• novorozenec MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

OBJECTIVE: Neonatal exposure to episodic hypoxemia and hyperoxemia is highly relevant to outcomes. Our goal was to investigate the differences in the frequency and duration of extreme low and high SpO2 episodes between automated and manual inspired oxygen control. DESIGN: Post-hoc analysis of a cohort from prospective randomized cross-over studies. SETTING: Seven tertiary care neonatal intensive care units. PATIENTS: Fifty-eight very preterm neonates (32 or less weeks PMA) receiving respiratory support and supplemental oxygen participating in an automated versus manual oxygen control cross-over trial. MAIN MEASURES: Extreme hypoxemia was defined as a SpO2 < 80%, extreme hyperoxemia as a SpO2 > 98%. Episode duration was categorized as < 5 seconds, between 5 to < 30 seconds, 30 to < 60 seconds, 60 to < 120 seconds, and 120 seconds or longer. RESULTS: The infants were of a median postmenstrual age of 29 (28-31) weeks, receiving a median FiO2 of 0.28 (0.25-0.32) with mostly receiving non-invasive respiratory support (83%). While most of the episodes were less than 30 seconds, longer episodes had a marked effect on total time exposure to extremes. The time differences in each of the three longest durations episodes (30, 60, and 120 seconds) were significantly less during automated than during manual control (p < 0.001). Nearly two-third of the reduction of total time spent at the extremes between automated and manual control (3.8 to 2.1% for < 80% SpO2 and 3.0 to 1.6% for > 98% SpO2) was seen in the episodes of at least 60 seconds. CONCLUSIONS: This study shows that the majority of episodes preterm infants spent in SpO2 extremes are of short duration regardless of manual or automated control. However, the infrequent longer episodes not only contribute the most to the total exposure, but also their reduction in frequency to the improvement associated with automated control.

• MeSH
• hypoxie etiologie   terapie   MeSH
• kojenec MeSH
• kyslík * MeSH
• lidé MeSH
• novorozenec nedonošený * MeSH
• novorozenec MeSH
• oxymetrie MeSH
• prospektivní studie MeSH
• retrospektivní studie MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• novorozenec MeSH
• Publikační typ
• časopisecké články MeSH