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.

References

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/US8789530
38.
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/10355/14374
43.
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/10355/40210
48.
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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