Multicenter Crossover Study of Automated Control of Inspired Oxygen in Ventilated Preterm Infants

Claure, Nelson; Bancalari, Eduardo; D'Ugard, Carmen; Nelin, Leif D.; Stein, Melanie; Ramanathan, Rangasamy; Hernandez, Richard; Donn, Steven M.; Becker, Michael A.; Bachman, Thomas E.

doi:10.1542/peds.2010-0939

Cited by 152 publications

(169 citation statements)

References 16 publications

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“…In a clinical setting, meeting SpO 2 target ranges depends-among others-on patient-caretaker ratio (31). Most closed loop studies compared automated to routine clinical care (14,21,(24)(25)(26), only one study could show a significant improvement comparing closed loop to dedicated manual control (22). In addition, in our study, alarm range was equal to target range, which created an ideal setting for dedicated manual control as caregivers are more effective in keeping SpO 2 within alarm limits then within target limits in preterm infants (32).…”

Section: Discussionmentioning

confidence: 99%

“…A promising solution to optimize oxygen therapy is the employment of an automatic "closed loop" system for regulation of FiO 2 based on SpO 2 . Several clinical trials with different devices have proven feasibility of automated closed loop FiO 2 control in the NICU for various modes of ventilation, mixed populations, and by using different algorithms (14,(21)(22)(23)(24)(25)(26). In addition, an overall reduction of manual interventions during automated control was found in these studies, indicating facilitation of caretakers and nursing staff in clinical routine (27,28).…”

mentioning

confidence: 81%

“…The average number of adjustments during resuscitation was similar in both groups (median 27, IQR (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35) vs. 28 (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36); P = 0.796). (Figure 1b), however the oxygen need was highly variable in both the automated (IQR (0.52-0.98)) and the manual group (IQR (0.37-0.72)).…”

Section: Resuscitationmentioning

confidence: 92%

“…In addition, an overall reduction of manual interventions during automated control was found in these studies, indicating facilitation of caretakers and nursing staff in clinical routine (27,28). However, at least one study raised concerns about safety, as time within target range was accompanied by an increase in time spent below saturation target range (25).…”

mentioning

confidence: 83%

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Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs

et al. 2015

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Articles Translational Investigation nature publishing groupBackground: Hyperoxia and hypoxia influence morbidity and mortality of preterm infants. Automated closed-loop control of the fraction of inspired oxygen (FiO 2 ) has been shown to facilitate oxygen supplementation in the neonatal intensive care unit (NICU), but has not yet been tested during preterm resuscitation. We hypothesized that fully automated FiO 2 control based on predefined oxygen saturation (SpO 2 ) targets was applicable in both preterm resuscitation and ventilation. Methods: Twenty-two preterm lambs were operatively delivered and intubated in a modified EXIT procedure. They were randomized to receive standardized resuscitation with either automated or manual FiO 2 control, targeting SpO 2 according to the Dawson curve in the first 10 min and SpO 2 90-95% hereafter. Automated FiO 2 control also was applied during surfactant replacement therapy and subsequent ventilation. results: Time within target range did not differ significantly between manual and automated FiO 2 control during resuscitation, however automated FiO 2 control significantly avoided hyperoxia. Automated FiO 2 control was feasible during surfactant replacement and kept SpO 2 within target range significantly better than manual control during subsequent ventilation. conclusion: In our model, fully automated FiO 2 control was feasible in rapidly changing physiologic conditions during postnatal resuscitation and prevented hyperoxia. We conclude that closed loop FiO 2 control is a promising tool for the delivery room.o xygen supplementation is one of the most common therapeutic interventions in resuscitation and neonatal intensive care of term and preterm infants (1). However, both hypoxia and hyperoxia must be avoided because of their detrimental effects on morbidity and mortality in these children. While hypoxia may lead to direct and indirect cellular damage, hyperoxia has been associated with oxygen toxicity, oxidative stress (2), and chronic diseases of preterm infants such as bronchopulmonary dysplasia (3) and retinopathy of prematurity (4).Increase in oxygenation after birth is a gradual process (5). Measurement of oxygen saturation (SpO 2 ) by pulse oximetry in the delivery room is feasible in newborn resuscitation (6) and in preterm infants within the first minutes of life (7). SpO 2 reference values of preterm infants increase within the first 10 min of life (5). This has led to SpO 2 target values incorporated in the current European Resuscitation Council guidelines on resuscitation of newborns (8). In order to avoid hyperoxia, current recommendations advise resuscitation of preterm infants with a mixture of air and oxygen, and to use fraction of inspired oxygen (FiO 2 ) between 0.21 and 0.30 (9). FiO 2 should subsequently be titrated according to SpO 2 (10,11). General use of pulse oximetry has been shown to extensively reduce O 2 -derived toxicity in preterm infants (12). However, keeping SpO 2 manually within changing saturation limits during a hectic period of resu...

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 81%

Section: Resuscitationmentioning

confidence: 92%

mentioning

confidence: 83%

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Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs

et al. 2015

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“…All studies except one were conducted in high‐income settings. These studies showed that, with manual titration, SpO 2 was outside and/or above the target range 18–84% and 15–58% of time, respectively 15, 16, 17, 18, 19, 20, 21, 22, 25, 26. In Colombia, SpO 2 was within or above the target 34 and 55% of the time, respectively 21.…”

mentioning

confidence: 98%

Pulse oximetry values of neonates admitted for care and receiving routine oxygen therapy at a resource‐limited hospital in Kenya

Morgan

Maina

Waiyego

et al. 2017

J Paediatrics Child Health

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AimThere are 2.7 million neonatal deaths annually, 75% of which occur in sub‐Saharan Africa and South Asia. Effective treatment of hypoxaemia through tailored oxygen therapy could reduce neonatal mortality and prevent oxygen toxicity.MethodsWe undertook a two‐part prospective study of neonates admitted to a neonatal unit in Nairobi, Kenya, between January and December 2015. We determined the prevalence of hypoxaemia and explored associations of clinical risk factors and signs of respiratory distress with hypoxaemia and mortality. After staff training on oxygen saturation (SpO2) target ranges, we enrolled a consecutive sample of neonates admitted for oxygen and measured SpO2 at 0, 6, 12, 18 and 24 h post‐admission. We estimated the proportion of neonates outside the target range (≥34 weeks: ≥92%; <34 weeks: 89–93%) with 95% confidence intervals (CIs).ResultsA total of 477 neonates were enrolled. Prevalence of hypoxaemia was 29.2%. Retractions (odds ratio (OR) 2.83, 95% CI 1.47–5.47), nasal flaring (OR 2.68, 95% CI 1.51–4.75), and grunting (OR 2.47, 95% CI 1.27–4.80) were significantly associated with hypoxaemia. Nasal flaring (OR 2.85, 95% CI 1.25–6.54), and hypoxaemia (OR 3.06, 95% CI 1.54–6.07) were significantly associated with mortality; 64% of neonates receiving oxygen were out of range at ≥2 time points and 43% at ≥3 time points.ConclusionThere is a high prevalence of hypoxaemia at admission and a strong association between hypoxaemia and mortality in this Kenyan neonatal unit. Many neonates had out of range SpO2 values while receiving oxygen. Further research is needed to test strategies aimed at improving the accuracy of oxygen provision in low‐resource settings.

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Automated oxygen delivery for preterm infants with respiratory dysfunction

Stafford,

Lai,

Tan

2023

Cochrane Database of Systematic Reviews

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Multicenter Crossover Study of Automated Control of Inspired Oxygen in Ventilated Preterm Infants

Abstract: In infants with fluctuations in Spo(2), automated Fio(2) adjustment improved maintenance of the intended Spo(2) range led to reduced time with high Spo(2) and more-frequent episodes with Spo(2) between 80% and 86%.

Cited by 152 publications

References 16 publications

Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs

Fully automated predictive intelligent control of oxygenation (PRICO) in resuscitation and ventilation of preterm lambs

Pulse oximetry values of neonates admitted for care and receiving routine oxygen therapy at a resource‐limited hospital in Kenya

Automated oxygen delivery for preterm infants with respiratory dysfunction

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