University of Edinburgh
The effect of implementing an automated oxygen control on oxygen saturation in preterm infantsVan Zanten HA1, Kuypers KLAM1, Stenson, BJ3, Bachman TE4, Pauws S 1 2, te Pas AB1 1Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands2TiCC, Tilburg University, the Netherlands3Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK4 Department of Biomedical Technology, Faculty of Biomedical Engineering, Czech Technical University, Prague, Czech RepublicKey Words: preterm infant, oxygen, hypoxaemia, hyperoxaemiaWord count:2396Corresponding author:H. A. van ZantenDepartment of Pediatrics, Division of NeonatologyLeiden University Medical Center, J6-S, PO Box 9600, 2300 RC Leiden, the NetherlandsTel: +31 71 5262859Email: h.a.van_zanten@lumc.nlWhat is already known on this topicThe frequency and duration of hypoxaemia and hyperoxaemia in preterm infants influence survival and long term outcome.Titrating oxygen manually to maintain oxygen saturation within a narrow target range can be challenging. Randomized trials have shown that automated oxygen control is effective, but this has only been measured for short periods. What this study addsAfter implementation of automated oxygen control for daily care, preterm infants spent more time with their oxygen saturation within the target range. After implementation, hyperoxaemia significantly decreased during oxygen therapy, but there was no effect on hypoxaemia.Contributors statementMs H.A. van Zanten was the executive researcher of the study. She performed literature search, data collection, data analysis, data interpretation, writing and submitting of the manuscript.Ms. K.L.A.M. Kuypers was involved in data collection, critically reviewed the manuscript and approved the final version.Mr. B.J. Stenson was involved in interpretation of the data, critically reviewed the manuscript and approved the final version.Mr. T. Bachman critically reviewed the manuscript and approved the final version. Mr. S. Pauws was involved in data analysis, critically reviewed the manuscript and approved the final version. Mr. A.B. te Pas was the project leader and performed literature search, designed the study, and coordinated data analysis, data interpretation, writing, editing, and submitting of the manuscript.AbstractObjective 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 (LUMC) 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 (interquartile range) 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). Conclusion 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.AbbreviationsFiO2Fraction of inspired oxygenGAGestational ageLUMCLeiden University Medical CentreNICUNeonatal intensive care unitsPDMSPatient data management systemSpO2Pulse oxygen saturationIntroductionTo prevent hypoxaemia and hyperoxaemia in preterm infants, nurses manually titrate the fraction of inspired oxygen (FiO2) in order to maintain pulse oximeter saturation (SpO2) within a set target range. Studies have shown that compliance with SpO2 targets is low and there is a tendency for nurses to accept higher SpO2.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bcm1icnVzdGVyPC9BdXRob3I+PFllYXI+MjAxMDwvWWVh
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ADDIN EN.CITE.DATA 6 7 We recently demonstrated that manual titration of oxygen therapy in preterm infants during these hypoxaemic and bradycardic events, led to unintended hyperoxaemia (SpO2 > 95%). ADDIN EN.CITE <EndNote><Cite><Author>van Zanten</Author><Year>2014</Year><RecNum>448</RecNum><DisplayText><style face="superscript">7</style></DisplayText><record><rec-number>448</rec-number><foreign-keys><key app="EN" db-id="xwf9xdxvwda5s0e52edpew0f9zx92zes0a2p" timestamp="1406190677">448</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>van Zanten, H. A.</author><author>Tan, R. N.</author><author>Thio, M.</author><author>de Man-van Ginkel, J. M.</author><author>van Zwet, E. W.</author><author>Lopriore, E.</author><author>Te Pas, A. B.</author></authors></contributors><auth-address>Department of Pediatrics, Division of Neonatology, Leiden University Medical Center, , Leiden, The Netherlands.</auth-address><titles><title>The risk for hyperoxaemia after apnoea, bradycardia and hypoxaemia in preterm infants</title><secondary-title>Arch Dis Child Fetal Neonatal Ed</secondary-title><alt-title>Archives of disease in childhood. Fetal and neonatal edition</alt-title></titles><periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></periodical><alt-periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></alt-periodical><edition>2014/03/29</edition><dates><year>2014</year><pub-dates><date>Mar 25</date></pub-dates></dates><isbn>1359-2998</isbn><accession-num>24668832</accession-num><urls><related-urls><url> Both hypoxaemia and hyperoxaemia are associated with morbidity (impaired growth, bronchopulmonary dysplasia, retinopathy of prematurity, cerebral injury) and mortality. Reducing periods of hypoxaemia and hyperoxaemia may improve survival and neurodevelopmental outcome.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bc2tpZTwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA 6 8-13Compliance in SpO2 targeting can be improved by training and implementation of guidelines.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmF3aXJhbjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 18 19 Randomized trials comparing automated FiO2 systems with manual titration for short periods, demonstrated an increase in the proportion of time spent with SpO2 within target range varying between 8-24%.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 20 24 25 However, the use of automated FiO2 control for longer periods has not been investigated.In the neonatal intensive care unit (NICU) in Leiden University Medical Center (LUMC) an automated FiO2 control system (Closed Loop of inspired Oxygen, Avea-CLiO2, CareFusion, Yorba Linda, California) was implemented and routinely used since August 2015 in order to improve the SpO2 targeting. We performed a retrospective study in preterm infants to evaluate automated FiO2 control when it was used as standard care and thus for a longer period. The aim was to compare the effectiveness of the automated FiO2 system versus manual titration of FiO2 in maintaining the SpO2 within the intended target range. MethodsA prospective observational study was performed in the NICU of the LUMC, which is a tertiary level perinatal center in the Netherlands with an average of 650 intensive care admissions per year. In the Netherlands, no ethical approval is required for anonymised studies with medical charts and patient data that were collected and noted for standard care. The LUMC Medical Ethics Committee provided a statement of no objection for obtaining and publishing the anonymised data. All preterm infants <30 weeks of gestation (GA) admitted to the NICU before and after the implementation of the automated FiO2 control in August 2015 (May 2015 - January 2016) receiving respiratory support (endotracheal and non-invasive ventilation) using the AVEA ventilator (CareFusion, Yorba Linda California) were included. Preterm infants with major congenital heart disease were excluded. The characteristics, of each infant as well as clinical parameters and ventilator settings (including FiO2 and SpO2) were sampled every minute and routinely collected in the patient data management system (PDMS) (Metavision; IMDsoft, Tel Aviv, Israel). During both periods the heart rate and SpO2 was collected using a neonatal pulse oximeter (Masimo Radical, Masimo Corporation, Irvine CA, USA) with an averaging time set at 8 seconds, integrated into the AVEA ventilator. Data was collected when infants received respiratory support by the AVEA and only included for analysis when supplemental oxygen was given, until the infants reached a gestational age of 32 weeks. After 32 weeks most infants are transferred out of the intensive care area in our unit or to a regional hospital, where no automated FiO2 control is available.During the manual and the automated FiO2 control periods, SpO2 was measured using a neonatal pulse oximeter integrated into the AVEA ventilator. During the manual period the nurses manually titrated the supplemental oxygen following local guidelines. During the automated period, an automated FiO2 control device integrated in the ventilator was used (CLiO2), in addition to manual adjustments. The CLiO2 function is a Closed-Loop controller designed to regulate FiO2 levels for preterm infants receiving support and oxygen from a mechanical ventilator. The FiO2 is automatically adjusted to maintain the SpO2 within the target range set by the clinician.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 26 The CLiO2 was turned off during episodes where SpO2 remained 100% for more than 30 minutes when FiO2 was 0.21 as recurrent alarms would occur. In case extra oxygen was needed again, the CLiO2 was switched on, and data analysis continued. The episodes without extra oxygen were not included in the analysis. In this study, for both manual and automated FiO2 control periods, the SpO2 target range was 90% to 95% during oxygen therapy. The alarm was activated if SpO2 was below 90% or above 95%. Before the start of each shift the set target range of the CliO2 and alarm settings were checked by the nurse. Also backup-FiO2 was checked before the start of each shift or when a procedure was performed (e.g. surfactant administration) and was adjusted if necessary. High FiO2 alarm was set at 70% with a delay of 60 seconds. All preterm infants received, as part of standard care, a loading dose of 10mg/kg caffeine followed by 5 mg/kg/day. Dopram (2 mg/kg/hr) was added in case of refractory apnoeas.The primary outcome was the percentage of time spent with SpO2 within the intended target range (90-95%) when FiO2 was >0.21. Also the percentage of time spent with SpO2 >95%, >98%, <90%, <85% and <80% were calculated. Hypoxaemia was defined as SpO2 <80% and hyperoxaemia as SpO2 >95%. Statistical analysesQuantitative data are presented as median (IQR), mean (SD) or number (percentage) as appropriate. Time with SpO2 within various ranges for FiO2 >21% were collated for each infant, and aggregated as percentages of the recorded time (median and IQR). A Kruskal-Wallis rank sum test was used to compare the percentage of time that SpO2 was within the target range of 90-95% between the manual period and the automated period. A Chi-square test was used to analyse discrete variables. If one of the cells had an expected count of less than five the Fisher’s exact test was used. Statistical analyses were performed by IBM SPSS Statistics version 23 and R 3.2.0 (R Core Team (2015). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL ).An increase of 10% of time that SpO2 was within the intended target range when using the automated FiO2 control was considered clinically relevant. On the basis of a previous study we estimated a standard deviation of 10%.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gS2FhbTwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+
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ADDIN EN.CITE.DATA 27 Therefore, 21 patients in each arm were required to detect a change of 10% SpO2-wtr between the periods with an 80% power and a significance level of 0.05. Results In a 9 month period, 42 infants with a GA<30 weeks were admitted and supported using the AVEA-ventilator, of which 21 infants < 30 weeks in four months before the implementation of the automated FiO2 control and 21 infants in five months after implementation (characteristics table 1). In one patient the CLiO2 was turned off for three days and during that period SpO2 data points were excluded from the analysis. In total, 234.541 data points (minute values) during the manual period and 392.211 data points (minute values) during the automated period were collected when FiO2 >21%. The median (IQR) number of data points per infant were not significantly different (manual vs. automated period: 4805 (1238 -16980) vs 16527 (1324 – 33625) data points; ns). The total number of days preterm infants were on respiratory support (with or without extra oxygen) were not different 16 (10-22) vs 14 (3-28) days; ns).Table SEQ Table \* ARABIC 1 Patient characteristics, manual vs automated oxygen titration period.Patients characteristicsN=42ManualN=21AutomatedN=21p ValueGestational age in weeks, median (IQR)27+6 (26+3 – 28+4)27+3 (26 – 28+2)0.2aBirth weight in grams, median (IQR)966 (843-1235)940 (825-1242)0.6aMales, n (%)10 (48)12 (57)0.5bApgar score 5 min, median (IQR)7 (6-9)8 (6-9)0.9aCaesarean delivery, n (%)10 (47.6)7 (33.3)0.3bSingletons, n (%)15 (71.4)10 (47.6)0.1bInvasive ventilated days, median (IQR)1 (0-8)2 (0-7)0.8aUse of dopram, n(%)7 (33)6 (28)0.7bMortality, n (%)0 (0)3 (14)0.2ca Statistical analysis comprised nonparametric Mann Whitney U test; b Statistical analysis comprised Chi square test; c Statistical analysis comprised Fisher’s Exact Test.After implementation of the automated FiO2 control, there was a slight, but significant decrease in median (IQR) SpO2 (manual vs automated: 94 (92 - 96)% vs 93 (91 - 95)%; p<0.001) (figure 1), while the FiO2 used increased (25 (24-29)% vs 27 (25-32)%; p< 0.009) (figure 2). The time spent with SpO2 within target range increased during the automated period (48.4 (41.5 - 56.4)% vs 61.9 (48.5 – 72.3)%; p <0.01) (distribution is given in figure 1). The time spent with SpO2 >95% significantly decreased during the automated period (41.9 (30.6 - 49.4)% vs 19.3 (11.5- 24.5)%; p<0.001) as did SpO2 >98% 10.1 (3.7 - 14.4)% vs 2.1(0.7 - 3.1)%, p<0.0005) (table 2). The time spent with SpO2 <90% significantly increased during the automated period (8.6 (7.2 - 11.7)% vs 15.1 (14.0 - 21.1)%; p<0.0001), which was mostly influenced by an increase in time SpO2 was between 85% and 89% (table 2). There was no significant difference in time spent with SpO2 <85% (2.7 (1.4 - 4.0)% vs 3.2 (1.8 - 5.1)%; ns), or % time with SpO2 <80% (1.1 (0.4 – 1.7)% vs 0.9 (0.5 - 2.1)%; ns). Figure SEQ figure \* ARABIC 1. Time with SpO2 within various ranges collated over all infants and aggregated as total proportion of recorded timeFigure SEQ figure \* ARABIC 2Time with FiO2 within various rangesTable SEQ Table \* ARABIC 2 Time with SpO2 values within and outside the target range with FiO2>21% Percentage of time, %Manual AutomatedP-value*SpO2 <80%, median (IQR)1.1 (0.4 - 1.7)0.9 (0.5 - 2.1)nsSpO2 <85%, median (IQR)2.7 (1.4 - 4.0)3.2 (1.8 - 5.1)nsSpO2 <90%, median (IQR)8.6 (7.2 - 11.7)15.1 (14.0 - 21.1)< 0.000190% ≤SpO2 ≤95%, median (IQR)48.4 (41.5 - 56.4)62.0 (56.4 - 68.6)< 0.01SpO2 of >95%, median (IQR)41.9 (30.6 - 49.4)19.3 (11.5 - 24.5)< 0.001SpO2 of >98%, median (IQR)10.1 (3.7 - 14.4)2.1 (0.7 - 3.1)< 0.0005Method: Time with SpO2 within various ranges were collated for each infant individually and aggregated as proportions of recorded time (median and IQR). *Statistical analysis comprised nonparametric Kruskal-Wallis rank sum test. SpO2, pulse oxygen saturation; FiO2, fraction of inspired oxygen.DiscussionWe observed that after implementing automated FiO2 control for routine care preterm infants spent significantly more time with SpO2 within their intended target range and less time with SpO2 above their intended target range, while FiO2 used was higher. Although the infants spent more time with SpO2 between 80% and 90% during automated FiO2 control, no significant effect on the time spent with hypoxaemia (SpO2<80%) was observed. It is likely that automatic FiO2 control had little effect on the infants’ intrinsic stability, but rather that correction of fluctuations in SpO2 were faster than during manual oxygen titration and with less overshoot. Further, the use of an automated device precludes the tendency of nurses to maintain the SpO2 in the higher end of the target range, which could lead to more hyperoxaemia.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bcm1icnVzdGVyPC9BdXRob3I+PFllYXI+MjAxMDwvWWVh
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ADDIN EN.CITE.DATA 6-13 26 Routine use of automated oxygen control has the potential to improve outcome in preterm infants.Randomized and non-randomized studies have compared short periods using automated FiO2 with manual titration.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 9 20-23 26-28 This is the first study reporting the impact when an automated FiO2 was implemented in routine care for longer periods. Although the previous studies showed that automated FiO2 control improved time spent with SpO2 within the intended target range, the short study periods may have increased the risk for a Hawthorne effect.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 9 20-23 26-28 We compared automated FiO2 with manual titration for a much longer period and observed a bigger increase in time SpO2 was within the target range than has been observed in other studies. This is important as it supports that in routine use, the potential for improvement of automated FiO2 is higher. This was not a randomized trial but our results reflect the effect of the automated FiO2 control when there was less risk that the attentiveness of caregivers was influenced by participating in a study. It is likely that the results of this study can be extrapolated to other level III NICU centers.Whether there was a decrease in time SpO2 was above or below the target range or both, varied between previous reported studies.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 9 20 22 23 26 28 While some studies of automated FiO2 control, observed a decrease in time spent with SpO2 below target ranges PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYWxsZW5iZXJnZXI8L0F1dGhvcj48WWVhcj4yMDE0PC9Z
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ADDIN EN.CITE.DATA 20 26 The CliO2 algorithm has been designed to prevent hyperoxaemia when overshoot occurs when the oxygen is increased. It is also known that nurses tend to give more liberal oxygen during desaturation resulting in a shorter duration with SpO2 below target range, but longer duration with time above target range. Indeed, in a previous study we reported that there is more awareness for alarms for SpO2 below the target range than above. ADDIN EN.CITE <EndNote><Cite><Author>van Zanten</Author><Year>2014</Year><RecNum>448</RecNum><DisplayText><style face="superscript">7</style></DisplayText><record><rec-number>448</rec-number><foreign-keys><key app="EN" db-id="xwf9xdxvwda5s0e52edpew0f9zx92zes0a2p" timestamp="1406190677">448</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>van Zanten, H. A.</author><author>Tan, R. N.</author><author>Thio, M.</author><author>de Man-van Ginkel, J. M.</author><author>van Zwet, E. W.</author><author>Lopriore, E.</author><author>Te Pas, A. B.</author></authors></contributors><auth-address>Department of Pediatrics, Division of Neonatology, Leiden University Medical Center, , Leiden, The Netherlands.</auth-address><titles><title>The risk for hyperoxaemia after apnoea, bradycardia and hypoxaemia in preterm infants</title><secondary-title>Arch Dis Child Fetal Neonatal Ed</secondary-title><alt-title>Archives of disease in childhood. Fetal and neonatal edition</alt-title></titles><periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></periodical><alt-periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></alt-periodical><edition>2014/03/29</edition><dates><year>2014</year><pub-dates><date>Mar 25</date></pub-dates></dates><isbn>1359-2998</isbn><accession-num>24668832</accession-num><urls><related-urls><url> Comparable to most previous studies, we could not detect a decrease in the total time with hypoxaemia when automated FiO2 was implemented. This likely reflects the aversion of caregivers to very low SpO2 values.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 9 20 23 26 Apparently the occurrence and depth of hypoxaemia is not prevented, but infants profit from a faster response provided by an automated FiO2 device when an hypoxaemic event occurs. The observed small increase in average FiO2 given could reflect the gradual downward titration defined by the algorithm of the device. Likewise, the gradual but constant downward titration of oxygen of the automated FiO2 control explains of the decrease in hyperoxaemia. It is possible that other devices for auto FiO2 control give different results as the algorithms can differ.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EYXJnYXZpbGxlPC9BdXRob3I+PFllYXI+MjAxNjwvWWVh
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ADDIN EN.CITE.DATA 29In considering the results of our study and others, it is clear that the SpO2 distribution achieved using manual control differs from that achieved using automated control, even when the intended target range is the same. ADDIN EN.CITE <EndNote><Cite><Author>Wilinska</Author><Year>2014</Year><RecNum>592</RecNum><DisplayText><style face="superscript">30</style></DisplayText><record><rec-number>592</rec-number><foreign-keys><key app="EN" db-id="xwf9xdxvwda5s0e52edpew0f9zx92zes0a2p" timestamp="1472733460">592</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wilinska, M.</author><author>Bachman, T.</author><author>Swietlinski, J.</author><author>Kostro, M.</author><author>Twardoch-Drozd, M.</author></authors></contributors><auth-address>Neonatology, The Medical Centre of Postgraduate Education, Marymoncka 99/103, Warsaw 01-813, Poland. wilinska.maria@.</auth-address><titles><title>Automated FiO2-SpO2 control system in neonates requiring respiratory support: a comparison of a standard to a narrow SpO2 control range</title><secondary-title>BMC Pediatr</secondary-title><alt-title>BMC pediatrics</alt-title></titles><periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></periodical><alt-periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></alt-periodical><pages>130</pages><volume>14</volume><edition>2014/06/03</edition><keywords><keyword>Continuous Positive Airway Pressure/*methods</keyword><keyword>Cross-Over Studies</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Linear Models</keyword><keyword>*Monitoring, Physiologic</keyword><keyword>Oxygen/*administration & dosage/metabolism</keyword><keyword>Positive-Pressure Respiration/*methods</keyword></keywords><dates><year>2014</year></dates><isbn>1471-2431</isbn><accession-num>24885124</accession-num><urls><related-urls><url> Others have also shown the effect of shifting automated control ranges. ADDIN EN.CITE <EndNote><Cite><Author>Wilinska</Author><Year>2014</Year><RecNum>592</RecNum><DisplayText><style face="superscript">30</style></DisplayText><record><rec-number>592</rec-number><foreign-keys><key app="EN" db-id="xwf9xdxvwda5s0e52edpew0f9zx92zes0a2p" timestamp="1472733460">592</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wilinska, M.</author><author>Bachman, T.</author><author>Swietlinski, J.</author><author>Kostro, M.</author><author>Twardoch-Drozd, M.</author></authors></contributors><auth-address>Neonatology, The Medical Centre of Postgraduate Education, Marymoncka 99/103, Warsaw 01-813, Poland. wilinska.maria@.</auth-address><titles><title>Automated FiO2-SpO2 control system in neonates requiring respiratory support: a comparison of a standard to a narrow SpO2 control range</title><secondary-title>BMC Pediatr</secondary-title><alt-title>BMC pediatrics</alt-title></titles><periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></periodical><alt-periodical><full-title>BMC Pediatr</full-title><abbr-1>BMC pediatrics</abbr-1></alt-periodical><pages>130</pages><volume>14</volume><edition>2014/06/03</edition><keywords><keyword>Continuous Positive Airway Pressure/*methods</keyword><keyword>Cross-Over Studies</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Linear Models</keyword><keyword>*Monitoring, Physiologic</keyword><keyword>Oxygen/*administration & dosage/metabolism</keyword><keyword>Positive-Pressure Respiration/*methods</keyword></keywords><dates><year>2014</year></dates><isbn>1471-2431</isbn><accession-num>24885124</accession-num><urls><related-urls><url> For that reason selecting the best target range for use with automated control should consider the likely SpO2 exposure and not just an adoption of the optimum standard of practice for manual control.This study was performed as an audit after implementation of automated FiO2 control as standard care in our unit. The results reflect the real situation as data was collected for the duration infants were admitted, while nurses taking care of them and where workload varied. Although the characteristics of the groups were similar, this was not a randomized study and it is possible that there were differences between the groups of infants admitted during the observed periods. We compared SpO2 values that were routinely sampled every minute and because the value is an average of 8 seconds, it is possible we missed SpO2 fluctuations in between the samples taken.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYWdlZGVzPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA 32 33 and it is likely that this is an accurate reflection of the SpO2 of the infants admitted.Reducing the occurrence and duration of hypoxaemia and hyperoxaemia is known to reduce the related morbidity and mortality. Currently randomized trials are planned to determine the effect of automated FiO2 on clinical outcome in preterm infants. ADDIN EN.CITE <EndNote><Cite><Author>Poets</Author><Year>2016</Year><RecNum>608</RecNum><DisplayText><style face="superscript">34</style></DisplayText><record><rec-number>608</rec-number><foreign-keys><key app="EN" db-id="xwf9xdxvwda5s0e52edpew0f9zx92zes0a2p" timestamp="1475844543">608</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Poets, C. F.</author><author>Franz, A. R.</author></authors></contributors><auth-address>Department of Neonatology, University Children's Hospital, Tubingen, Germany.
Department of Neonatology, University Children's Hospital, Tubingen, Germany Center for Pediatric Clinical Studies, University Children's Hospital, Tubingen, Germany.</auth-address><titles><title>Automated FiO2 control: nice to have, or an essential addition to neonatal intensive care?</title><secondary-title>Arch Dis Child Fetal Neonatal Ed</secondary-title><alt-title>Archives of disease in childhood. Fetal and neonatal edition</alt-title></titles><periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></periodical><alt-periodical><full-title>Arch Dis Child Fetal Neonatal Ed</full-title><abbr-1>Archives of disease in childhood. Fetal and neonatal edition</abbr-1></alt-periodical><edition>2016/10/05</edition><keywords><keyword>Oxygen</keyword><keyword>neonatal intensive care</keyword><keyword>very low birthweight infant</keyword></keywords><dates><year>2016</year><pub-dates><date>Oct 3</date></pub-dates></dates><isbn>1359-2998</isbn><accession-num>27698194</accession-num><urls><related-urls><url> In anticipation of these upcoming trials, we implemented the automated FiO2 as standard care for all infants receiving respiratory support in the NICU as part of a quality improvement in our unit. Although difficult to measure, during evaluations nurses reported that after implementation of the automated FiO2 control their workload was less and they would be very reluctant to go back to the manual titration. Studies have reported that automated FiO2 control decreased the required nursing time in preterm infants with frequent severe desaturations.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGF1cmU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 20 24 25 However, thresholds should be set very carefully in order not to mask deterioration of a patient and nurses needs to stay attentive as well as the automated FiO2 control should give a warning if the FiO2 baseline rises above a predefined level. In conclusion, implementation of automated FiO2 control led to an increased compliance of maintaining SpO2 within the intended target range during oxygen therapy, with a decrease in the time SpO2>95% and SpO2>98%. Although the observed effects of the automated FiO2 control have the potential to improve outcome, this study was not designed to demonstrate this. Randomised studies are needed to confirm the beneficial effects of the automated FiO2 control on the outcome of preterm infants.References ADDIN EN.REFLIST 1. Armbruster J, Schmidt B, Poets CF, et al. Nurses compliance with alarm limits for pulse oximetry: Qualitative study. Journal of Perinatology 2010;30(8):531-34. doi: 10.1038/jp.2009.1892. Clucas L, Doyle LW, Dawson J, et al. Compliance with alarm limits for pulse oximetry in very preterm infants. Pediatrics 2007;119(6):1056-60. doi: 10.1542/peds.2006-3099 [published Online First: 2007/06/05]3. Mills BA, Davis PG, Donath SM, et al. Improving compliance with pulse oximetry alarm limits for very preterm infants? Journal of Paediatrics and Child Health 2010;46(5):255-8. doi: 10.1111/j.1440-1754.2009.01680.x [published Online First: 2010/03/27]4. Nghiem TH, Hagadorn JI, Terrin N, et al. Nurse opinions and pulse oximeter saturation target limits for preterm infants. Pediatrics 2008;121(5):e1039-46. doi: 10.1542/peds.2007-2257 [published Online First: 2008/05/03]5. Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Archives of disease in childhood Fetal and neonatal edition 2011;96(2):F93-8. doi: 10.1136/adc.2009.178616 [published Online First: 2010/11/03]6. Bancalari E, Claure N. Control of Oxygenation During Mechanical Ventilation in the Premature Infant. Clinics in Perinatology 2012;39(3):563-+.7. van Zanten HA, Tan RN, Thio M, et al. The risk for hyperoxaemia after apnoea, bradycardia and hypoxaemia in preterm infants. Archives of Disease in Childhood Fetal and Neonatal edition 2014 doi: 10.1136/archdischild-2013-305745 [published Online First: 2014/03/29]8. Askie LM, Brocklehurst P, Darlow BA, et al. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatrics 2011;11:6. doi: 10.1186/1471-2431-11-6 [published Online First: 2011/01/18]9. Claure N, Bancalari E. Automated closed loop control of inspired oxygen concentration. RespirCare 2013;58(1):151-61.10. Di Fiore JM, Bloom JN, Orge F, et al. A Higher Incidence of Intermittent Hypoxemic Episodes Is Associated with Severe Retinopathy of Prematurity. Journal of Pediatrics 2010;157(1):69-73.11. Kaufman DA, Zanelli SA, Gurka MJ, et al. Time outside targeted oxygen saturation range and retinopathy of prematurity. Early Hum Dev 2014;90 Suppl 2:S35-40. doi: 10.1016/s0378-3782(14)50010-2 [published Online First: 2014/09/16]12. Poets CF, Roberts RS, Schmidt B, et al. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA 2015;314(6):595-603. doi: 10.1001/jama.2015.8841 [published Online First: 2015/08/12]13. Saugstad OD, Aune D. In search of the optimal oxygen saturation for extremely low birth weight infants: a systematic review and meta-analysis. Neonatology 2011;100(1):1-8. doi: 10.1159/000322001 [published Online First: 2010/12/15]14. Arawiran J, Curry J, Welde L, et al. Sojourn in excessively high oxygen saturation ranges in individual, very low-birthweight neonates. Acta Paediatrica (Oslo, Norway : 1992) 2014 doi: 10.1111/apa.12827 [published Online First: 2014/10/17]15. Deuber C, Abbasi S, Schwoebel A, et al. The toxigen initiative: targeting oxygen saturation to avoid sequelae in very preterm infants. Advances in Neonatal Care 2013;13(2):139-45. doi: 10.1097/ANC.0b013e31828913cc [published Online First: 2013/03/28]16. Ford SP, Leick-Rude MK, Meinert KA, et al. Overcoming barriers to oxygen saturation targeting. Pediatrics 2006;118 Suppl 2:S177-86. doi: 10.1542/peds.2006-0913P [published Online First: 2006/11/03]17. Lau YY, Tay YY, Shah VA, et al. Maintaining optimal oxygen saturation in premature infants. The Permanente Journal 2011;15(1):e108-13. [published Online First: 2011/09/06]18. Claure N, Bancalari E. Closed-loop control of inspired oxygen in premature infants. Seminars in Fetal and Neonatal Medicine 2015;20(3):198-204. doi: . Fathabadi OS, Gale TJ, Olivier JC, et al. Automated control of inspired oxygen for preterm infants: What we have and what we need. Biomedical Signal Processing and Control 2016;28:9-18. doi: . Claure N, Bancalari E, D'Ugard C, et al. Multicenter Crossover Study of Automated Control of Inspired Oxygen in Ventilated Preterm Infants. Pediatrics 2011;127(1):E76-E83.21. Hallenberger A, Poets CF, Horn W, et al. Closed-loop automatic oxygen control (CLAC) in preterm infants: a randomized controlled trial. Pediatrics 2014;133(2):e379-85. doi: 10.1542/peds.2013-1834 [published Online First: 2014/01/29]22. Urschitz MS, Horn W, Seyfang A, et al. Automatic control of the inspired oxygen fraction in preterm infants: a randomized crossover trial. Am J Respir Crit Care Med 2004;170(10):1095-100. doi: 10.1164/rccm.200407-929OC [published Online First: 2004/09/07]23. Zapata J, Gomez JJ, Araque Campo R, et al. A randomised controlled trial of an automated oxygen delivery algorithm for preterm neonates receiving supplemental oxygen without mechanical ventilation. Acta Paediatrica (Oslo, Norway : 1992) 2014;103(9):928-33. doi: 10.1111/apa.12684 [published Online First: 2014/05/13]24. Claure N, Bancalari E. Role of automation in neonatal respiratory support. Journal of Perinatal Medicine 2013;41(1):115-8. doi: 10.1515/jpm-2012-0031 [published Online First: 2012/10/25]25. Wilinska M, Bachman T, Swietlinskli J. Time required for effective FiO2-titration in preterm infants: a comparison. Neonatal Intensive Care 2012;25(5):44-46.26. Claure N, D'Ugard C, Bancalari E. Automated adjustment of inspired oxygen in preterm infants with frequent fluctuations in oxygenation: a pilot clinical trial. The Journal of Pediatrics 2009;155(5):640-5 e1-2. doi: 10.1016/j.jpeds.2009.04.057 [published Online First: 2009/07/15]27. van Kaam AH, Hummler HD, Wilinska M, et al. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. The Journal of Pediatrics 2015;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012 [published Online First: 2015/07/07]28. Lal M, Tin W, Sinha S. Automated control of inspired oxygen in ventilated preterm infants: crossover physiological study. Acta Paediatrica (Oslo, Norway : 1992) 2015;104(11):1084-9. doi: 10.1111/apa.13137 [published Online First: 2015/07/22]29. Dargaville PA, Sadeghi Fathabadi O, Plottier GK, et al. Development and preclinical testing of an adaptive algorithm for automated control of inspired oxygen in the preterm infant. Archives of Disease in Childhood Fetal and Neonatal edition 2016 doi: 10.1136/archdischild-2016-310650 [published Online First: 2016/09/17]30. Wilinska M, Bachman T, Swietlinski J, et al. Automated FiO2-SpO2 control system in neonates requiring respiratory support: a comparison of a standard to a narrow SpO2 control range. BMC Pediatrics 2014;14:130. doi: 10.1186/1471-2431-14-130 [published Online First: 2014/06/03]31. Vagedes J, Poets CF, Dietz K. Averaging time, desaturation level, duration and extent. Archives of Disease in Childhood Fetal and Neonatal edition 2013;98(3):F265-6. doi: 10.1136/archdischild-2012-302543 [published Online First: 2012/09/11]32. Carlo WA, Finer NN, Walsh MC, et al. Target ranges of oxygen saturation in extremely preterm infants. The New England Journal of Medicine 2010;362(21):1959-69. doi: 10.1056/NEJMoa0911781 [published Online First: 2010/05/18]33. Schmidt B, Whyte RK, Asztalos EV, et al. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial. JAMA 2013;309(20):2111-20.34. Poets CF, Franz AR. Automated FiO2 control: nice to have, or an essential addition to neonatal intensive care? Archives of Disease in Childhood Fetal and Neonatal edition 2016 doi: 10.1136/archdischild-2016-311647 [published Online First: 2016/10/05]Figure legendsFigure 1 Time with SpO2 within various ranges collated over all infants and aggregated as total proportion of recorded time Histogram on Left side; Manual period : Histogram right side; Automated periodThe smoothed bell-shaped line represents a fitted normal density function parameterized by the empirical mean and standard deviation estimated from the proportion data of recorded time within various SpO2 ranges. The distribution of the proportional recorded time data is slightly negatively skewed with a long tail at the left and a higher mass at the right-hand side, when compared with a normal distribution.Figure 2 Time with FiO2 within various ranges were collated over all infants and aggregated as total proportion of recorded time. Histogram on Left side; Manual period : Histogram right side; Automated period ................
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