Automated control of oxygen titration in preterm infants on non-invasive respiratory support

Author(s):  
Peter A Dargaville ◽  
Andrew P Marshall ◽  
Oliver J Ladlow ◽  
Charlotte Bannink ◽  
Rohan Jayakar ◽  
...  

ObjectiveTo evaluate the performance of a rapidly responsive adaptive algorithm (VDL1.1) for automated oxygen control in preterm infants with respiratory insufficiency.DesignInterventional cross-over study of a 24-hour period of automated oxygen control compared with aggregated data from two flanking periods of manual control (12 hours each).SettingNeonatal intensive care unit.ParticipantsPreterm infants receiving non-invasive respiratory support and supplemental oxygen; median birth gestation 27 weeks (IQR 26–28) and postnatal age 17 (12–23) days.InterventionAutomated oxygen titration with the VDL1.1 algorithm, with the incoming SpO2 signal derived from a standard oximetry probe, and the computed inspired oxygen concentration (FiO2) adjustments actuated by a motorised blender. The desired SpO2 range was 90%–94%, with bedside clinicians able to make corrective manual FiO2 adjustments at all times.Main outcome measuresTarget range (TR) time (SpO2 90%–94% or 90%–100% if in air), periods of SpO2 deviation, number of manual FiO2 adjustments and oxygen requirement were compared between automated and manual control periods.ResultsIn 60 cross-over studies in 35 infants, automated oxygen titration resulted in greater TR time (manual 58 (51–64)% vs automated 81 (72–85)%, p<0.001), less time at both extremes of oxygenation and considerably fewer prolonged hypoxaemic and hyperoxaemic episodes. The algorithm functioned effectively in every infant. Manual FiO2 adjustments were infrequent during automated control (0.11 adjustments/hour), and oxygen requirements were similar (manual 28 (25–32)% and automated 26 (24–32)%, p=0.13).ConclusionThe VDL1.1 algorithm was safe and effective in SpO2 targeting in preterm infants on non-invasive respiratory support.Trial registration numberACTRN12616000300471.

Author(s):  
Peter R Reynolds ◽  
Thomas L Miller ◽  
Leonithas I Volakis ◽  
Nicky Holland ◽  
George C Dungan ◽  
...  

ObjectiveTo evaluate a prototype automated controller (IntellO2) of the inspired fraction of oxygen (FiO2) in maintaining a target range of oxygen saturation (SpO2) in preterm babies receiving nasal high flow (HF) via the Vapotherm Precision Flow.DesignProspective two-centre order-randomised cross-over study.SettingNeonatal intensive care units.PatientsPreterm infants receiving HF with FiO2 ≥25%.InterventionAutomated versus manual control of FiO2 to maintain a target SpO2 range of 90%–95% (or 90%–100% if FiO2=21%).Main outcome measuresThe primary outcome measure was per cent of time spent within target SpO2 range. Secondary outcomes included the overall proportion and durations of SpO2 within specified hyperoxic and hypoxic ranges and the number of in-range episodes per hour.ResultsData were analysed from 30 preterm infants with median (IQR) gestation at birth of 26 (24–27) weeks, study age of 29 (18–53) days and study weight 1080 (959–1443) g. The target SpO2 range was achieved 80% of the time on automated (IntellO2) control (IQR 70%–87%) compared with 49% under manual control (IQR 40%–57%; p<0.0001). There were fewer episodes of SpO2 below 80% lasting at least 60 s under automated control (0 (IQR 0–1.25)) compared with manual control (5 (IQR 2.75–14)). There were no differences in the number of episodes per hour of SpO2 above 98% (4.5 (IQR 1.8–8.5) vs 5.5 (IQR 1.9–14); p=0.572) between the study arms.ConclusionsThe IntellO2 automated oxygen controller maintained patients in the target SpO2 range significantly better than manual adjustments in preterm babies receiving HF.Trial registration numberNCT02074774.


Author(s):  
Hylke H Salverda ◽  
Sophie J E Cramer ◽  
Ruben S G M Witlox ◽  
Timothy J Gale ◽  
Peter A Dargaville ◽  
...  

ObjectiveTo compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DesignRandomised cross-over study.SettingTertiary level neonatal unit in the Netherlands.PatientsPreterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%–95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days–27 weeks 6 days) and postnatal age 19 (IQR 17–24) days.InterventionsInspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.Main outcome measuresTime spent within set SpO2 TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen).ResultsTime spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6–82.4)% vs 68.5 (56.7–79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1–9.9)% vs 15.9 (11.5–30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%–17.2%) vs 9.3 (8.2–12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1–1.0)% vs 0.2 (0.1–0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.ConclusionsThe OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.Trial registry numberNCT03877198


Author(s):  
Christoph E Schwarz ◽  
Karen B Kreutzer ◽  
Lukas Langanky ◽  
Nicole S Wolf ◽  
Wolfgang Braun ◽  
...  

ObjectiveAutomatic control (SPOC) of the fraction of inspired oxygen (FiO2), based on continuous analysis of pulse oximeter saturation (SpO2), improves the proportion of time preterm infants spend within a specified SpO2-target range (Target%). We evaluated if a revised SPOC algorithm (SPOCnew, including an upper limit for FiO2) compared to both routine manual control (RMC) and the previously tested algorithm (SPOCold, unrestricted maximum FiO2) increases Target%, and evaluated the effect of the pulse oximeter’s averaging time on controlling the SpO2 signal during SPOC periods.DesignUnblinded, randomised controlled crossover study comparing 2 SPOC algorithms and 2 SpO2 averaging times in random order: 12 hours SPOCnew and 12 hours SPOCold (averaging time 2 s or 8 s for 6 hours each) were compared with 6-hour RMC. A generated list of random numbers was used for allocation sequence.SettingUniversity-affiliated tertiary neonatal intensive care unit, GermanyPatientsTwenty-four infants on non-invasive respiratory support with FiO2 >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585 g and 30 days).Main outcome measureTarget%.ResultsMean (SD) [95% CI] Target% was 56% (9) [52, 59] for RMC versus 69% (9) [65, 72] for SPOCold_2s, 70% (7) [67, 73] for SPOCnew_2s, 71% (8) [68, 74] for SPOCold_8s and 72% (8) [69, 75] for SPOCnew_8s.ConclusionsIrrespective of SpO2-averaging time, Target% was higher with both SPOC algorithms compared to RMC. Despite limiting the maximum FiO2, SPOCnew remained significantly better at maintaining SpO2 within target range compared to RMC.Trial registrationNCT03785899


Author(s):  
Vrinda Nair ◽  
Mithilesh Kumar Lal ◽  
Jenna Gillone ◽  
Prakash Kannan Loganathan ◽  
Thomas Edward Bachman

ObjectiveThe objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%–95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2).DesignA single-centre randomised crossover study.SettingsA level III neonatal intensive care unit.PatientsPreterm infants receiving mechanical ventilation and oxygen requirement >21%.InterventionsVolume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2).OutcomesThe primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%–95%) .ResultsNineteen preterm infants with a median gestation age 25 weeks (IQR: 24–28) and birth weight 685 g (IQR: 595–980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57–81) in VG vs 75% (58–83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups.ConclusionThere was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study.Trial registration numberNCT03865069.


2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e35-e36
Author(s):  
Brigitte Lemyre ◽  
Thierry Lacaze-Masmonteil ◽  
Prakesh Shah ◽  
Jaya Bodani ◽  
Stefanie Doucette ◽  
...  

Abstract Primary Subject area Neonatal-Perinatal Medicine Background There is a paucity of comparative effectiveness data for bovine lipid extract surfactant (BLES) and poractant alfa (Curosurf). Objectives To compare duration of respiratory support and short-term outcomes in very preterm infants treated with bovine lipid extract surfactant and poractant alfa. Design/Methods We performed a prospective, multicentre, comparative effectiveness study. Thirteen Canadian level III neonatal intensive care units (NICUs) provided bovine lipid extract surfactant to infants born &lt;32 weeks’ gestational age (GA) for a set period of time in the year 2019 (3 to 9 months), then changed to poractant alfa for the remainder of the year. The primary outcome was total duration of respiratory support (invasive and non-invasive). We utilized the Canadian Neonatal Network database for all study data. Results A total of 968 eligible infants (530 infants &lt; 28 weeks’ GA and 438 infants 280-316weeks’ GA) were included, of which 494 received bovine lipid extract surfactant and 474 received poractant alfa. In unadjusted analysis, no difference was observed in total duration of any respiratory support (median 38 vs. 40.5 days). After adjusting for baseline characteristics and accounting for cluster effects, infants treated with poractant alfa spent a median of 4.16 fewer days on respiratory support (95% CI 0.05, 8.28 days). This reduction was observed in the subgroup of infants 280-316 weeks’ GA, but not in those &lt; 28 weeks’ GA, and was explained by their shorter time on non-invasive respiratory support. No differences were observed in the need to re-dose surfactant, hospital mortality, bronchopulmonary dysplasia, or length of stay in NICU. Conclusion Administration of poractant alfa was associated with shorter median duration of respiratory support compared to bovine lipid extract surfactant in preterm neonates &lt; 32 weeks’ GA.


Author(s):  
Risha Bhatia ◽  
Hazel R Carlisle ◽  
Ruth K Armstrong ◽  
C Omar Farouk Kamlin ◽  
Peter G Davis ◽  
...  

ObjectiveTo evaluate the feasibility of electrical impedance tomography (EIT) to describe the regional tidal ventilation (VT) and change in end-expiratory lung volume (EELV) patterns in preterm infants during the process of extubation from invasive to non-invasive respiratory support.DesignProspective observational study.SettingSingle-centre tertiary neonatal intensive care unit.PatientsPreterm infants born <32 weeks’ gestation who were being extubated to nasal continuous positive airway pressure as per clinician discretion.InterventionsEIT measurements were taken in supine infants during elective extubation from synchronised positive pressure ventilation (SIPPV) before extubation, during and then at 2 and 20 min after commencing nasal continuous positive applied pressure (nCPAP). Extubation and pressure settings were determined by clinicians.Main outcome measuresGlobal and regional ΔEELV and ΔVT, heart rate, respiratory rate and oxygen saturation were measured throughout.ResultsThirty infants of median (range) 2 (1, 21) days were extubated to a median (range) CPAP 7 (6, 8) cm H2O. SpO2/FiO2 ratio was a mean (95% CI) 50 (35, 65) lower 20 min after nCPAP compared with SIPPV. EELV was lower at all points after extubation compared with SIPPV, and EELV loss was primarily in the ventral lung (p=0.04). VT was increased immediately after extubation, especially in the central and ventral regions of the lung, but the application of nCPAP returned VT to pre-extubation patterns.ConclusionsEIT was able to describe the complex lung conditions occurring during extubation to nCPAP, specifically lung volume loss and greater use of the dorsal lung. EIT may have a role in guiding peri-extubation respiratory support.


Author(s):  
Hylke H Salverda ◽  
Sophie J E Cramer ◽  
Ruben S G M Witlox ◽  
Peter A Dargaville ◽  
Arjan B te Pas

BackgroundAutomated oxygen control systems are finding their way into contemporary ventilators for preterm infants, each with its own algorithm, strategy and effect.ObjectiveTo provide guidance to clinicians seeking to comprehend automated oxygen control and possibly introduce this technology in their practice.MethodA narrative review of the commercially available devices using different algorithms incorporating rule-based, proportional-integral-derivative and adaptive concepts are described and explained. An overview of how they work and, if available, the clinical effect is given.ResultsAll algorithms have shown a beneficial effect on the proportion of time that oxygen saturation is within target range, and a decrease in hyperoxia and severe hypoxia. Automated oxygen control may also reduce the workload for bedside staff. There is concern that such devices could mask clinical deterioration, however this has not been reported to date.ConclusionsSo far, trials involving different algorithms are heterogenous in design and no head-to-head comparisons have been made, making it difficult to differentiate which algorithm is most effective and what clinicians can expect from algorithms under certain conditions.


Author(s):  
Koen P Dijkman ◽  
Thilo Mohns ◽  
Jeanne P Dieleman ◽  
Carola van Pul ◽  
Tom G Goos ◽  
...  

ObjectiveTo investigate the efficacy of automated control of inspired oxygen (FiO2) by Predictive Intelligent Control of Oxygenation (PRICO) on the Fabian ventilator in maintaining oxygen saturation (SpO2) in preterm infants on high flow nasal cannula (HFNC) support.DesignSingle-centre randomised two-period crossover study.SettingTertiary neonatal intensive care unit.Patients27 preterm infants (gestational age (GA) <30 weeks) on HFNC support with FiO2 >0.25.InterventionA 24-hour period on automated FiO2-control with PRICO compared with a 24-hour period on routine manual control (RMC) to maintain a SpO2 level within target range of 88%–95% measured at 30 s intervals.Main outcome measuresPrimary outcome: time spent within target range (88%–95%). Secondary outcomes: time spent above and below target range, in severe hypoxia (SpO2 <80%) and hyperoxia (SpO2 >98%), mean SpO2 and FiO2 and manual FiO2 adjustments.Results15 patients received PRICO-RMC and 12 RMC-PRICO. The mean time within the target range increased with PRICO: 10.8% (95% CI 7.6 to 13.9). There was a decrease in time below target range: 7.6% (95% CI 4.2 to 11.0), above target range: 3.1% (95% CI 2.9 to 6.2) and in severe hypoxia: 0.9% (95% CI 1.5 to 0.2). We found no difference in time spent in severe hyperoxia. Mean FiO2 was higher during PRICO: 0.019 (95% CI 0.006 to 0.030). With PRICO there was a reduction of manual adjustments: 9/24 hours (95% CI 6 to 12).ConclusionIn preterm infants on HFNC support, automated FiO2-control by PRICO is superior to RMC in maintaining SpO2 within target range. Further validation studies with a higher sample frequency and different ventilation modes are needed.


2022 ◽  
Vol 9 ◽  
Author(s):  
Shu-Hua Lai ◽  
Ying-Ling Xie ◽  
Zhi-Qin Chen ◽  
Rong Chen ◽  
Wen-Hong Cai ◽  
...  

Objectives: The aim of this study was to investigate the safety and feasibility of nHFOV as initial respiratory support in preterm infants with RDS.Methods: This study retrospectively analyzed the clinical data of 244 premature infants with RDS who were treated in our hospital from January 2016 to January 2019 and divided into the nHFOV group (n = 115) and the BiPAP group (n = 129) based on the initial respiratory support method.Results: Respiratory outcomes showed that the rate of NIV failure during the first 72 hours of life in the nHFOV group was significantly lower than that in the BiPAP group. The time of NIV in the nHFOV group was significantly shorter than that in the BiPAP group. The time of supplemental oxygen in the nHFOV group was significantly shorter than that in the BiPAP group. The incidence of air leakage syndrome in the nHFOV group was significantly lower than that in the BiPAP group, and the length of hospital stay of the nHFOV group was also significantly shorter than that in the BiPAP group. Although the rate of infants diagnosed with BPD was similar between the two groups, the rate of severe BPD in the nHFOV group was significantly lower than that in the BiPAP group.Conclusion: This study showed that nHFOV as initial respiratory support for preterm infants with RDS was feasible and safe compared to BiPAP. Furthermore, nHFOV can reduce the need for IMV and reduce the incidence of severe BPD and air leak syndrome.


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