Premature infants often require respiratory support with a varying concentration of the fraction of inspired oxygen FiO2 to keep the arterial oxygen saturation typically measured using a peripheral sensor (SpO2) within the desired range to avoid both hypoxia and hyperoxia. The widespread practice for controlling the fraction of inspired oxygen is by manual adjustment. Automatic control of the oxygen to assist care providers is desired. A novel closed-loop respiratory support device with dynamic adaptability is evaluated nonclinically by using a neonatal respiratory response model. The device demonstrated the ability to improve oxygen saturation control over manual control by increasing the proportion of time where SpO2 is within the desired range while minimizing the episodes and periods where SpO2 of the neonatal respiratory model is out of the target range.
Issue Section:
Research Papers
References
1.
Gardner
, S. L.
, Carter
, B. S.
, Enzman-Hines
, M.
, and Hernandez
, J. A.
, 2011
, Merenstein & Gardner's Handbook of Neonatal Intensive Care
, Mosby Elsevier
, St. Louis, MO
.2.
Mccolm
, J. R.
, and Fleck
, B. W.
, 2001
, “Retinopathy of Prematurity: Causation
,” Semin. Neonatol.
, 6
(6
), pp. 453
–460
.3.
Saugstad
, O. D.
, 2003
, “Bronchopulmonary Dysplasia—Oxidative Stress and Antioxidants
,” Semin. Neonatol.
, 8
(1
), pp. 39
–49
.4.
Silverman
, W. A.
, 2004
, “A Cautionary Tale About Supplemental Oxygen: The Albatross of Neonatal Medicine
,” Pediatrics
, 113
(2
), pp. 394
–396
.5.
Hagadorn
, J. I.
, Furey
, A. M.
, Nghiem
, T.-H.
, Schmid
, C. H.
, Phelps
, D. L.
, Pillers
, D.-A. M.
, and Cole
, C. H.
, 2006
, “Achieved Versus Intended Pulse Oximeter Saturation in Infants Born Less Than 28 Weeks' Gestation: The AVIOx Study
,” Pediatrics
, 118
(4
), pp. 1574
–1582
.6.
Laptook
, A.
, Salhab
, W.
, Allen
, J.
, Saha
, S.
, and Walsh
, M.
, 2006
, “Pulse Oximetry in Very Low Birth Weight Infants: Can Oxygen Saturation Be Maintained in the Desired Range?
,” J. Perinatol.
, 26
(6
), pp. 337
–341
.7.
Ford
, S. P.
, Leick-Rude
, M. K.
, Meinert
, K. A.
, Anderson
, B.
, Sheehan
, M. B.
, Haney
, B. M.
, Leeks
, S. R.
, Simon
, S. D.
, and Jackson
, J. K.
, 2006
, “Overcoming Barriers to Oxygen Saturation Targeting
,” Pediatrics
, 118
(Suppl. 2
), pp. S177
–S186
.8.
Lim
, K.
, Wheeler
, K. I.
, Gale
, T. J.
, Jackson
, H. D.
, Kihlstrand
, J. F.
, Sand
, C.
, Dawson
, J. A.
, and Dargaville
, P. A.
, 2014
, “Oxygen Saturation Targeting in Preterm Infants Receiving Continuous Positive Airway Pressure
,” J. Pediatr.
, 164
(4
), pp. 730
–736
.9.
Clarke
, A.
, Yeomans
, E.
, Elsayed
, K.
, Medhurst
, A.
, Berger
, P.
, Skuza
, E.
, and Tan
, K.
, 2014
, “A Randomised Crossover Trial of Clinical Algorithm for Oxygen Saturation Targeting in Preterm Infants With Frequent Desaturation Episodes
,” Neonatology
, 107
(2
), pp. 130
–136
.10.
Sink
, D. W.
, Hope
, S. A. E.
, and Hagadorn
, J. I.
, 2011
, “Nurse: Patient Ratio and Achievement of Oxygen Saturation Goals in Premature Infants
,” Arch. Dis. Child.-Fetal Neonat. Ed.
, 96
(2
), pp. F93
–F98
.11.
Fathabadi
, O. S.
, Gale
, T. J.
, Olivier
, J.
, and Dargaville
, P. A.
, 2016
, “Automated Control of Inspired Oxygen for Preterm Infants: What We Have and What We Need
,” Biomed. Signal Process. Control
, 28
, pp. 9
–18
.12.
Collins
, P.
, Levy
, N.
, Beddis
, I.
, Godfrey
, S.
, and Silverman
, M.
, 1979
, “Apparatus for the Servocontrol of Arterial Oxygen Tension in Preterm Infants
,” Med. Biol. Eng. Comput.
, 17
(4
), pp. 449
–452
.13.
Beddis
, I.
, Collins
, P.
, Levy
, N.
, Godfrey
, S.
, and Silverman
, M.
, 1979
, “New Technique for Servo-Control of Arterial Oxygen Tension in Preterm Infants
,” Arch. Dis. Child.
, 54
(4
), pp. 278
–280
.14.
Åström
, K. J.
, 1980
, “A Robust Sampled Regulator for Stable Systems With Monotone Step Responses
,” Automatica
, 16
(3
), pp. 313
–315
.15.
Sano
, A.
, and Kikucki
, M.
, 1985, “Adaptive Control of Arterial Oxygen Pressure of Newborn Infants Under Incubator Oxygen Treatments
,” IEE Proc. D (Control Theory Appl.)
, 132
(5
), pp. 205
–211
.16.
Yu
, C.
, He
, W.
, So
, J. M.
, Roy
, R.
, Kaufman
, H.
, and Newell
, J. C.
, 1987
, “Improvement in Arteral Oxygen Control Using Multiple-Model Adaptive Control Procedures
,” IEEE Trans. Biomed. Eng.
, 34
(8
), pp. 567
–574
.17.
Tehrani
, F. T.
, 1990
, “Computer Simulation of the Respiratory Control System in the Newborn Infant
,” 12th Annual International Conference of the IEEE Engineering in Medicine and Biology Society
, Philadelphia, PA, Nov. 1–4, pp. 1848
–1850
.18.
Tehrani
, F. T.
, 1993
, “Mathematical Analysis and Computer Simulation of the Respiratory System in the Newborn Infant
,” IEEE Trans. Biomed. Eng.
, 40
(5
), pp. 475
–481
.19.
Morozoff
, P. E.
, Evans
, R. W.
, and Smyth
, J. A.
, 1993
, “Automatic Control of Blood Oxygen Saturation in Premature Infants
,” Second IEEE Conference on Control Applications
, Vancouver, BC, Canada, Sept. 13–16, pp. 415
–419
.20.
Sun
, Y.
, Kohane
, I.
, and Stark
, A.
, 1994, “Fuzzy Logic Assisted Control of Inspired Oxygen in Ventilated Newborn Infants
,” Annual Symposium on Computer Application in Medical Care
, New York, pp. 757
–761
.21.
Sun
, Y.
, Kohane
, I. S.
, and Stark
, A. R.
, 1997
, “Computer-Assisted Adjustment of Inspired Oxygen Concentration Improves Control of Oxygen Saturation in Newborn Infants Requiring Mechanical Ventilation
,” J. Pediatr.
, 131
(5
), pp. 754
–756
.22.
Urschitz
, M. S.
, Horn
, W.
, Seyfang
, A.
, Hallenberger
, A.
, Herberts
, T.
, Miksch
, S.
, Popow
, C.
, Mu¨ller-Hansen
, I.
, and Poets
, C. F.
, 2004
, “Automatic Control of the Inspired Oxygen Fraction in Preterm Infants: A Randomized Crossover Trial
,” Am. J. Respir. Crit. Care Med.
, 170
(10
), pp. 1095
–1100
.23.
Morozoff
, E. P.
, and Smyth
, J. A.
, 2009
, “Evaluation of Three Automatic Oxygen Therapy Control Algorithms on Ventilated Low Birth Weight Neonates
,” Annual International Conference of the IEEE Engineering in Medicine and Biology Society
(EMBS
), Minneapolis, MN, Sept. 3–6, pp. 3079
–3082
.24.
Claure
, N.
, Bancalari
, E.
, D'Ugard
, C.
, Nelin
, L.
, Stein
, M.
, Ramanathan
, R.
, Hernandez
, R.
, Donn
, S. M.
, Becker
, M.
, and Bachman
, T.
, 2011
, “Multicenter Crossover Study of Automated Control of Inspired Oxygen in Ventilated Preterm Infants
,” Pediatrics
, 127
(1
), pp. e76
–e83
.25.
Claure
, N.
, and Bancalari
, E.
, 2013
, “Automated Closed Loop Control of Inspired Oxygen Concentration
,” Respir. Care
, 58
(1
), pp. 151
–161
.26.
Hummler
, H.
, Fuchs
, H.
, and Schmid
, M.
, 2014
, “Automated Adjustments of Inspired Fraction of Oxygen to Avoid Hypoxemia and Hyperoxemia in Neonates—A Systematic Review on Clinical Studies
,” Klin. Pädiatr.
, 226
(4
), pp. 204
–210
.27.
Hallenberger
, A.
, Poets
, C. F.
, Horn
, W.
, Seyfang
, A.
, and Urschitz
, M. S.
, 2014
, “Closed-Loop Automatic Oxygen Control (CLAC) in Preterm Infants: A Randomized Controlled Trial
,” Pediatrics
, 133
(2
), pp. e379
–e385
.28.
López
, J. A.
, Campo
, R. A.
, and Rubio
, A. M.
, 2014
, “Automixer: Equipment for the Reduction of Risks Associated With Inadequate Oxygen Supply
,” Ing. Invest.
, 34
(1
), pp. 60
–65
.29.
Claure
, N.
, and Bancalari
, E.
, 2015, “Closed-Loop Control of Inspired Oxygen in Premature Infants
,” Semin. Fetal Neonat. Med.
, 20
(3
), pp. 198
–204
.30.
Van Kaam
, A. H.
, Hummler
, H. D.
, Wilinska
, M.
, Swietlinski
, J.
, Lal
, M. K.
, Te Pas
, A. B.
, Lista
, G.
, Gupta
, S.
, Fajardo
, C. A.
, and Onland
, W.
, 2015
, “Automated Versus Manual Oxygen Control With Different Saturation Targets and Modes of Respiratory Support in Preterm Infants
,” J. Pediatr.
, 167
(3
), pp. 545
–550
.31.
Lal
, M.
, Tin
, W.
, and Sinha
, S.
, 2015
, “Automated Control of Inspired Oxygen in Ventilated Preterm Infants: Crossover Physiological Study
,” Acta Paediatr.
, 104
(11
), pp. 1084
–1089
.32.
Dargaville
, P.
, Fathabadi
, O.
S., Plottier
, G.
, Lim
, K.
, Wheeler
, K.
, Jayakar
, R.
, and Gale
, T.
, 2016
, “Development and Preclinical Testing of an Adaptive Algorithm for Automated Control of Inspired Oxygen in the Preterm Infant
,” Arch. Dis. Child.-Fetal Neonat. Ed.
, 102
, pp. F31
–F36
.33.
Plottier
, G. K.
, Wheeler
, K. I.
, Ali
, S. K.
, Fathabadi
, O. S.
, Jayakar
, R.
, Gale
, T. J.
, and Dargaville
, P. A.
, 2016
, “Clinical Evaluation of a Novel Adaptive Algorithm for Automated Control of Oxygen Therapy in Preterm Infants on Non-Invasive Respiratory Support
,” Arch. Dis. Child.-Fetal Neonat. Ed.
, 102
(1), pp. F37–F43.34.
Bancalari
, E.
, and Claure
, N.
, 2012
, “Control of Oxygenation During Mechanical Ventilation in the Premature Infant
,” Clin. Perinatol.
, 39
(3
), pp. 563
–572
.35.
Claure
, N.
, 2007
, “Automated Regulation of Inspired Oxygen in Preterm Infants: Oxygenation Stability and Clinician Workload
,” Anesth. Analg.
, 105
(6
), pp. S37
–S41
.36.
Keim
, T.
, Amjad
, R.
, and Fales
, R.
, 2011
, “Modeling and Feedback Control of Inspired Oxygen for Premature Infants
,” ASME
Paper No. DSCC2011-6107.37.
Amjad
, R.
, Fales
, R.
, and Keim
, T.
, 2014
, “Closed Loop Respiratory Support Device With Dynamic Adaptability
,” University of Missouri System, Columbia, MO, U.S. Patent No. US8789530B2
.https://patents.google.com/patent/US878953038.
Keim
, T.
, Amjad
, R.
, and Fales
, R.
, 2009
, “Modeling and Control of the Oxygen Saturation in Neonatal Infants
,” ASME
Paper No. DSCC2009-2682.39.
Krone
, B.
, Fales
, R.
, and Amjad
, R.
, 2011
, “Model of Neonatal Infant Blood Oxygen Saturation
,” ASME
Paper No. DSCC2011-6182.40.
Fathabadi
, O. S.
, Gale
, T. J.
, Lim
, K.
, Salmon
, B. P.
, Dawson
, J. A.
, Wheeler
, K. I.
, Olivier
, J. C.
, and Dargaville
, P. A.
, 2015
, “Characterisation of the Oxygenation Response to Inspired Oxygen Adjustments in Preterm Infants
,” Neonatology
, 109
(1
), pp. 37
–43
.41.
Keim
, T.
, 2011
, “Control of Arterial Oxygen Saturation in Premature Infants
,” Ph.D. thesis, University of Missouri, Columbia, MO.42.
Krone
, B.
, 2011
, “Modeling and Control of Arterial Oxygen Saturation in Premature Infants
,” M.S. thesis
, University of Missouri, Columbia, MO.http://hdl.handle.net/10355/1437443.
Yu
, C.
, 1986
, “An Arterial Oxygen Saturation Controller
,” Rensselaer Polytechnic Institute
, Troy, NY
.44.
Severinghaus
, J. W.
, 1979
, “Simple, Accurate Equations for Human Blood O2 Dissociation Computations
,” J. Appl. Physiol.
, 46
(3
), pp. 599
–602
.45.
Nitzan
, M.
, and Taitelbaum
, H.
, 2008
, “The Measurement of Oxygen Saturation in Arterial and Venous Blood
,” IEEE Instrum. Meas. Mag.
, 11
(3
), pp. 9–15.46.
Fathabadi
, O. S.
, Gale
, T.
, Lim
, K.
, Salmon
, B.
, Wheeler
, K.
, Olivier
, J.
, and Dargaville
, P.
, 2014
, “Assessment of Validity and Predictability of the FiO2–SpO2 Transfer-Function in Preterm Infants
,” Physiol. Meas.
, 35
(7
), pp. 1425
–1437
.47.
Quigley
, D.
, 2013
, “Control of Arterial Hemoglobin Saturation in Premature Infants Using H-Infinity Synthesis and Performance Specifications From Best Clinical Practice
,” M.S. thesis
, University of Missouri, Columbia, MO.http://hdl.handle.net/10355/4021048.
Chow
, L. C.
, Wright
, K. W.
, and Sola
, A.
, 2003
, “Can Changes in Clinical Practice Decrease the Incidence of Severe Retinopathy of Prematurity in Very Low Birth Weight Infants?
,” Pediatrics
, 111
(2
), pp. 339
–345
.49.
Lau
, Y. Y.
, Tay
, Y. Y.
, Shah
, V. A.
, Chang
, P.
, and Loh
, K. T.
, 2011
, “Maintaining Optimal Oxygen Saturation in Premature Infants
,” Perm. J.
, 15
(1
), pp. e108–e113.50.
Montgomery
, D. C.
, 1991
, Design and Analysis of Experiments
, Wiley
, Hoboken, NJ.51.
Hicks
, C. R.
, and Turner
, K. V.
, 1999
, Fundamental Concepts in the Design of Experiments
, Oxford University Press
, New York.52.
Chang
, M.
, 2011
, “Optimal Oxygen Saturation in Premature Infants
,” Korean J. Pediatr.
, 54
(9
), pp. 359
–362
.53.
Wilinska
, M.
, Bachman
, T.
, Swietlinski
, J.
, Kostro
, M.
, and Twardoch-Drozd
, M.
, 2014
, “Automated FiO2-SpO2 Control System in Neonates Requiring Respiratory Support: A Comparison of a Standard to a Narrow SpO2 Control Range
,” BMC Pediatr.
, 14
(1
), p. 130
.54.
Peck
, R.
, and Devore
, J. L.
, 2011
, Statistics: The Exploration & Analysis of Data
, Cengage Learning
, Boston, MA.55.
Claure
, N.
, Gerhardt
, T.
, Everett
, R.
, Musante
, G.
, Herrera
, C.
, and Bancalari
, E.
, 2001
, “Closed-Loop Controlled Inspired Oxygen Concentration for Mechanically Ventilated Very Low Birth Weight Infants With Frequent Episodes of Hypoxemia
,” Pediatrics
, 107
(5
), pp. 1120
–1124
.56.
Van Zanten
, H.
, Tan
, R.
, Thio
, M.
, De Man-Van Ginkel
, J.
, Van Zwet
, E.
, Lopriore
, E.
, and Te Pas
, A.
, 2014
, “The Risk for Hyperoxaemia After Apnoea, Bradycardia and Hypoxaemia in Preterm Infants
,” Arch. Dis. Child.-Fetal Neonat. Ed.
, 99
(4
), pp. F269
–F273
.57.
Nelson
, L.
, and Stear
, E.
, 1976
, “The Simultaneous On-Line Estimation of Parameters and States in Linear Systems
,” IEEE Trans. Autom. Control
, 21
(1
), pp. 94
–98
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