A novel preterm respiratory mechanics active simulator to test

the performances of neonatal pulmonary ventilators

Paolo Cappa
a),b)
Department of Mechanics and Aeronautics, University of Rome LA SAPIENZA, Via Eudossiana 18,
00184 Rome, Italy
Salvatore Andrea Sciuto
a),c)
Department of Mechanical and Industrial Engineering, University of Rome ROMA TRE, Via della Vasca
Navale 79, 00146 Rome, Italy
Sergio Silvestri
a),d)
School of Biomedical Engineering, University CAMPUS BIO-MEDICO, Via Longoni 83,
00155 Rome, Italy
Received 28 November 2001; accepted for publication 26 March 2002
A patient active simulator is proposed which is capable of reproducing values of the parameters of
pulmonary mechanics of healthy newborns and preterm pathological infants. The implemented
prototype is able to: a let the operator choose the respiratory pattern, times of apnea, episodes of
cough, sobs, etc., b continuously regulate and control the parameters characterizing the pulmonary
system; and, nally, c reproduce the attempt of breathing of a preterm infant. Taking into account
both the limitation due to the chosen application eld and the preliminary autocalibration phase
automatically carried out by the proposed device, accuracy and reliability on the order of 1% is
estimated. The previously indicated value has to be considered satisfactory in light of the eld of
application and the small values of the simulated parameters. Finally, the achieved metrological
characteristics allow the described neonatal simulator to be adopted as a reference device to test
performances of neonatal ventilators and, more specically, to measure the time elapsed between the
occurrence of a potentially dangerous condition to the patient and the activation of the
corresponding alarm of the tested ventilator. 2002 American Institute of Physics.
DOI: 10.1063/1.1480453
I. INTRODUCTION
Nearly 60% of newborn babies with severe respiratory
diseases need ventilatory support performed by means of as-
sisted or controlled mechanical ventilation. This task is gen-
erally fullled by pulmonary ventilators specically de-
signed for neonatal use. The constraints for infant pulmonary
ventilators are denitely more severe in terms of reliability,
stability, and accuracy, due to the following indicated rea-
sons. First, the small volumes delivered to the patient, in the
range of about 4 ml per breath, represent a strict constraint to
the design of the tester. Second, further constraints are: a
the extreme delicateness and vulnerability of the neonatal
respiratory system, mainly due to both the reduced mass of a
preterm infant which can be in the order of 0.5 kg, and b
the highest tolerable lung pressures that should be less than
about 1.01.5 kPa 1015 cm H
2
O.
14
Third, the typical
time length of the treatment, that can even last longer than
three months, induces further limitation to the design of the
experimental setup.
As is well known, the ventilation system Fig. 1 is com-
posed of a pulmonary ventilator, an inspiration and expira-
tion circuit, a humidier, an endotracheal tube, and a patient.
Depending on both the specic behavior of each component
and the high number of parameters characterizing the men-
tioned system, difculties immediately emerge in the evalu-
ation of the performances of this intensive care equipment in
terms of the actual amount of gaseous mixture that reaches
the alveolus-blood capillary interface, especially when the
patients are very small i.e., premature infants at 56 months
gestational period. Moreover, most of the commercially
available neonatal ventilators measure pressure and ow
only at ventilator level, i.e., upstream the inspiratory circuit
see Fig. 1. As a consequence, the actual values of air pres-
sure in the bronchial tree and volume delivered to the alveoli
are not directly measured in situ but calculated on the basis
of the parameter values measured upstream the circuit and
correcting them to take into account a standard pressure drop
and a standard compressible volume along the inspiratory
and expiratory tube. Therefore, it seems obvious that in the
case of very small patients, like preterm infants, the ne
regulation of the pulmonary ventilator parameters requires
specic attention because it can cause pathologies of the pul-
monary apparatus. Neonatal pediatricians are particularly
worried about iatrogenic damages that frequently occur in
newborn babies subjected to mechanical ventilation, mainly
because of their critical conditions and the vulnerability of
a
Present address: Clinical Engineering Service, Childrens Hospital BAM-
BINO GESU
`
of Rome, piazza S. Onofrio 4, 00165, Rome, Italy.
b
Electronic mail: paolo.cappa@uniroma1.it
c
Electronic mail: sciuto@uniroma3.it
d
Electronic mail: s.silvestri@unicampus.it
REVIEW OF SCIENTIFIC INSTRUMENTS VOLUME 73, NUMBER 6 JUNE 2002
2411 0034-6748/2002/73(6)/2411/6/$19.00 2002 American Institute of Physics
their cardiorespiratory apparatus.
5,6
Finally, during the treat-
ment, unpredictable events, such as coughs, sobs, and sighs,
can cause the patient to breath against the ventilator that is
supposed to recognize such events and adapt its operating
conditions in order to avoid dangerous situations.
7
The aforementioned reasons, in addition to fatalities
caused by an inadequate ventilation
810
showed the necessity
to test the performances of neonatal ventilators by means of
an active mechanical simulator of the respiratory system spe-
cic for a preterm infant. Such a device should be able to: a
provide similar physiological mechanical characteristics of
the pulmonary system, even in pathological conditions, b
simulate unexpected events, and, nally, c monitor online
respiratory parameters such as airway pressure, volume, and
ow. The analysis carried out on specic scientic literature
and on instrumentation presently in the market outlined the
lack of testers able to simulate mechanical properties of
lungs in the whole range of premature infant respiratory pa-
thologies. This issue is conrmed by the specic needs pre-
sented by some pathologies associated with an elevated stiff-
ness of the respiratory system, such as neonatal respiratory
distress syndrome NRDS associated with a low pulmonary
compliance on the order of 1 ml/kPa 0.1 ml/cm H
2
O, in
connection to small volumes delivered per breath. In fact,
commercially available active simulators generally use com-
pliant rubber bellows,
11,12
often equipped with springs,
13,14
or
rigid containers
15,16
to simulate pulmonary compliances but
in a limited range of variations
17
and are not able to reach
low compliance values such as those previously indicated.
Moreover, passive simulators, mainly devoted to test venti-
lator performances in an endurance test, are currently cov-
ered by International
18
and American
19,20
standards and are
based on mechanical systems composed by tubes, resis-
tances, and compliances, such as rigid volumes, manufac-
tured with standard dimensions. International Standards Or-
ganization ISO standard,
18
for example, denes the values
of a pulmonary mechanical tester for infant and adult venti-
lators; more specically, the values of compliance C and
resistance R indicated for infant simulation are respectively
equal to 10 ml/kPa 1 ml/cm H
2
O and 5 kPa s l
1
50 cm
H
2
O s l
1
. However, these values are not representative of
the complete range of possible pathological conditions of
premature newborns:
21,22
in fact, for these patients, C can
reach
23
values that lie in the range of 140 ml/kPa 0.14.0
ml/cm H
2
O and R can vary in the range
24
from 3 to 15 kPa s
l
1
30 to 150 cm H
2
O s l
1
. Furthermore, some very repu-
table worldwide manufacturers of testers for biomedical in-
strumentation commercialize pulmonary simulators not in-
tended for exclusive infant use. However, none of these
devices is able to reach the herein reported C and R values,
they are only able to simulate C values in the range from 10
to 1019 ml/kPa 1 to 100 ml/cm H
2
O and a lower value for
tidal volume, i.e., the amount of air inspired during each
breath, equal to 5 ml only while, in the presence of NRDS or
broncopulmonary disease BPD, it can be lower than 4 ml.
From the aforementioned synthesized considerations, the
usefulness of a device able to simulate the mentioned values
of respiratory parameters specic for healthy and pathologi-
cal conditions for neonatal patients emerges. Therefore, the
main task of the present article is to design an innovative
tester for pulmonary ventilators specic for infant use. Then,
a prototype has been implemented and metrologically char-
acterized in order to be utilized to test infant pulmonary ven-
tilators.
II. INSTRUMENT DESCRIPTION
A novel device is proposed and realized in order to ac-
curately and reliably reproduce the preterm respiratory me-
chanics. The simulator is composed of two main parts, sche-
matically represented in Fig. 2, the electronic unit EU and
the pneumatic/mechanical unit PMU. The EU consists of a
personal computer PC able to operate a software control of
the PMU through a digital to analog D/A 12-bit converter
and an analog to digital A/D 16-bit converter; both convert-
ers are available on the same multi-input/output plug-and-
play data conversion board. The software was specically
designed to allow the operator to set all the parameters useful
to characterize a chosen respiratory pattern, i.e., tidal vol-
ume, frequency, inspiratory and expiratory time, type of
simulated pathology, apnea periods, sobs, coughs, and other
unexpected events, through an easy-to-use graphical user in-
terface. The respiratory pattern is then repeated any number
of times according to the chosen test time length. The D/A
converts the programmed digital pattern, representing the
respiratory volume changes, into an analog voltage signal to
drive the shaker S through a power amplier PA. The
airway pressure and ow are measured by means of specic
transducers T. Signals provided by transducers are then l-
FIG. 1. Scheme of the ventilation system.
FIG. 2. Schematic representation of the infant pulmonary simulator. A/D
and D/A, analog to digital and digital to analog converters; B, bellows; CR,
clamp resistance; EF, elliptic lters; EU, electronic unit; T, ow and pres-
sure transducers; PA, power amplier; PC, personal computer; PMU,
pneumatic/mechanical unit; PV, pulmonary ventilator; S, electromechanical
shaker; SC, three-way stopcock; and VAO, ventilator analog outputs.
2412 Rev. Sci. Instrum., Vol. 73, No. 6, June 2002 Cappa, Sciuto, and Silvestri
tered by means of an elliptic low-pass lter
25
EF in order to
drastically reduce noise due to air humidity and ow turbu-
lence, and to avoid aliasing in data acquisition. Pressure,
ow, and alarm signals provided as ventilator analog outputs
VAO are directly gathered by the data conversion board.
Once digitized, signals are postprocessed to calculate pulmo-
nary parameters to be displayed on the PC monitor. Methods
and equations to calculate the whole set of respiratory me-
chanical parameters from pressure and ow wave forms are
software implemented to online visualize and continuously
update the parameter mean values with the associated stan-
dard deviations. As a nal task, the simulator allows the
storing and printing of the respiratory parameter trend as a
function of time for further evaluation by physicians and
technicians. As further processing, a program routine evalu-
ates: a the delay time of ventilator apnea alarm since the
beginning of simulated apnea by the tester and b the differ-
ences between the set respiratory parameters and those mea-
sured and visualized by the examined pulmonary ventilator.
A ow chart of the methodology of the device is reported in
Fig. 3.
As regards the PMU, it is necessary to observe that pre-
vious studies
26
conrm that, even though each of the millions
of alveoli could act as a separate mechanical unit, the me-
chanics of normal or pathological lungs during quiet breath-
ing can be represented by a single or double compartment
model. As a consequence, a double compartment model has
been chosen to simulate, by means of lumped parameters, the
mechanical behavior of two lungs with different mechanical
characteristics. Thus, the PMU of the device consists of two
silicone bellows B of compliance certied by the
manufacturer
27
both connected to an electromechanical
shaker S that is able at the initial phase to drive their ex-
pansion during inspiratory phase, by means of the volume
variation law generated by the software, and then to induce
their collapse during the expiratory phase. One of the two
bellows is placed in a specically designed damping system
described more fully in the following section in order to have
a compartment with variable compliance and to avoid high-
frequency turbulent ow oscillations that led previous efforts
in making infant pulmonary simulators to fail due to a poor
data repeatability.
11,28
In particular, the variation of the bel-
low volume as a function of time is indicated as critical for
the simulation of ne compliance variations in respiratory
patterns associated with pathological conditions.
Bellows are connected to the articial trachea through
two tubes and a three-way stopcock SC which permits the
exclusion of one of two bellows in order to simulate sym-
metric pulmonary diseases. The three-way SC can be substi-
tuted by a simple Y piece in the case of simulation of asym-
metric diseases, i.e., the frequent case of a pathology
affecting only one lung, where an intrapulmonary shunt is
realized by means of the difference of the mechanical char-
acteristics of the lungs in order to actuate the typical low-
frequency oscillations in pressure and ow signals.
The pressure transducer
29
is placed between the articial
trachea and the bellows to measure, at lung level, the relative
pressure induced by the volume change of the pneumatic
system. As tidal volume was chosen as the control variable
for actuator feedback, a high accuracy level is required on its
measurement. Tidal volume is then measured by digital inte-
gration of air ow passing through the articial trachea by
means of a volume measurement procedure implemented in
the proposed system and accomplished by means of a high
accuracy owmeter.
30
The chosen owmeter is based on a
double hot wire anemometer
31
specically designed for in-
fant respiratory measurements and placed in a rigid 5 mm
diameter cylinder. One of the anemometers is shielded on
one side in order to allow this device to discriminate the
direction of ow. The integrator was previously calibrated by
means of a 10 ml syringe placed into an infusion pump able
to generate a constant 0.1 ml/s ow. In consideration of the
metrological performances of the owmeter, the overall ac-
curacy in volume variation measurements was equal to about
0.02 ml for a breathing frequency range from 20 to 120
breath per minute bpm. In consideration of the aforemen-
tioned observations, the chosen ow transducer presents the
following advantages: a the accuracy is adequate to mea-
sure small ows like those produced by preterm infant
breathing,
32
b it allows one to discriminate the direction of
ow, c due to its reduced dimensions, it adds an unnotice-
able dead space to the breathing circuit, d introduces a low
pressure drop,
33
and, nally, e depending on the operating
temperature of the wires, about 400 C, it is not affected by
condensate.
During system calibration, temperature and pressure test
areas have been monitored and their effects on transducer
calibration curves were found negligible, conrming data
FIG. 3. Flow chart of the infant pulmonary simulator methodology.
2413 Rev. Sci. Instrum., Vol. 73, No. 6, June 2002 Active neonatal breathing simulator
sheet values provided by manufacturers. With reference to
Fig. 4, one bellow was placed in a cylindrical container
34
partially lled up with about 300 ml of oil, in order to obtain
low values for the simulated pulmonary compliance. The
controlled damping system was implemented with two per-
forated disks aligned with the bellows; the lower disk LD
was xed to the container and the upper disk UD could be
rotated by an axial rod. The relative position of the UD with
respect to the LD allows one to set the orices span OS
where oil ows through during bellow expansion or collapse.
As is well known, pressure drop across an orice is depen-
dent on uid dynamic viscosity, , and cross-sectional area
of the orice itself. As dynamic uid viscosity strongly de-
pends on temperature, a diathermic oil
35
was chosen and its
temperature was continuously monitored during preliminary
tests, performed in accordance to the conguration shown in
Fig. 4. The mentioned tests are conducted in order to evalu-
ate the relationship between the damping force of the system,
the orice cross-sectional area, and the operating oil tem-
perature. The data collected showed negligible effects in-
duced by temperature variations in the range of the observed
test area temperature, i.e., 235 C. Moreover, the men-
tioned preliminary tests outlined that the amount of oil in the
container and, more specically its level upon the perforated
disks, is critical due to three main reasons: a the thermal
capacity and the heat dissipation of the oil, b the hydro-
static pressure on the bellow, and, nally, c a minimum
level is necessary to reduce boundary effects of oil efux
through the holes during breathing simulation in such a man-
ner as to increase the system repeatability. During these tests,
a xed amount of oil was gradually added to the container
and an optimal level of 20 mm over the disks was found
leading to standard deviations less than 1% for each of the
monitored respiratory parameters.
To complete the simulator setup, a variable clamp resis-
tance CR, see Fig. 4, was placed along the articial trachea
AT to simulate the upper airway resistance to ow. The
lowest value of air ow, in the order of 0.5 l/min, is reached
by manually reducing the AT section.
III. PERFORMANCE EVALUATION AND DISCUSSION
In order to evaluate the performances of the realized
tester, it is important to outline that, as previously mentioned,
the respiratory mechanics of the preterm patient are simu-
lated by means of a rst-order system due to the almost
negligible mass of the delivered air to the patient. Thus,
simulator behavior can be characterized completely by
means of a single characteristic parameter, i.e., the time con-
stant , representing the product of an elastic term, the lung
compliance, and a resistive one, the airway resistance. There-
fore, once the pathology and the patient characteristics to
simulate are chosen, the tidal volume and are unequivo-
cally dened. As a consequence, the evaluation of the met-
rological performances of the implemented device was con-
ducted by paying particular attention to the simulation of
pulmonary compliance that is the most critical parameter of
an infant respiratory simulator. In fact, when is individual-
ized, it is possible to impose a C value, with the resulting
value of R consequently determined. It should be noted that,
even though with the described prototype, it is not possible
to change R and C independently, this does not represent a
limitation. In fact, as reported in Ref. 25, airway resistance in
pulmonary function tests is calculated, at rest breathing rates,
as the ratio R/C, and, then, R is not representative of the
only hydrodynamic airway resistance to ow but, more gen-
erally, of the dissipation of the whole respiratory system. In
particular, the proposed prototype allows one to regulate the
compliance value in two different ways: a by changing disk
OS, which leads to a different damping force exerted on the
bellows during breathing volume variations, and b by
modifying the shape of the exponential signal that drives
bellow collapse during the expiratory phase, i.e., varying its
time constant .
At the initial stage, it was decided to conduct prelimi-
nary acquisition on healthy patients by means of a commer-
cially available ow transducer and examining the available
scientic literature. So, on the basis of the previously con-
ducted tests, best signals simulating the normal respiratory
volume variation as a function of time were found as com-
posed by a sequence of two exponential functions. The rst
wave form, simulating the inspiratory phase, is characterized
by a positive slope and a time constant
i
and it is represen-
tative of muscle integrity and the ability to drive lung expan-
sion; the latter has a negative slope and a time constant
e
,
representing a passive expiration, i.e., the free evolution of a
rst-order system, such as lungs and chest wall at low
breathing rates, and depends only on the mechanical charac-
teristics of the system. The implemented software allows one
to modify both values in order to simulate diseases affect-
ing respiratory muscles or pulmonary parenchyma. Several
FIG. 4. Representation of the PMU. AT, articial trachea; CR, clamp resis-
tance; FT, ow transducer; LD, lower disk; OS, orice span gray area; PT,
pressure transducer; PV, pulmonary ventilator; and UD, upper disk.
2414 Rev. Sci. Instrum., Vol. 73, No. 6, June 2002 Cappa, Sciuto, and Silvestri
tests have been carried out to determine the relationship be-
tween the simulated pulmonary compliance calculated by
MeadWhittenberger method
36
and the orice opening
percentage.
37
OS was increased by 10% steps and measure-
ments were carried out during ve day tests for each OS
value at environmental laboratory conditions. Results re-
ported in Fig. 5 show an almost linear relation between com-
pliance and OS with R
2
0.9334 and a standard deviation
always lower than 8% that is generally assumed as
acceptable.
38
Despite each value associated with a specic
OS percentage result within the limits stated by ISO, the
measured values were considered too high to fulll the
constraint imposed by adequate compliance accuracy for a
simulated range from 2 to 6ml/kPa 0.2 to 0.6 ml/cm H
2
O.
Thus, it was decided to choose 0%, 30%, 60% and 100% OS
values as a coarse compliance regulation, adopting as a ne
regulation the variation of
e
relative to the expiration driv-
ing signal in order to achieve compliance values even less
than 2.0 ml/kPa 0.20 ml/cm H
2
O with an accuracy in the
order of 0.5 ml/kPa 0.05 ml/cm H
2
O. As a further remark,
it is necessary to observe that in case of OS equal to 100%,
the simulated compliance higher value corresponds to the
one characteristic of the bellow. Finally, whereas the reduc-
tion of OS implies a reduction of tidal volume due to higher
friction forces developed also in the inspiratory phase, the
reduction of
e
relative to the expiratory wave form leaves
the tidal volume reached in the inspiratory phase unchanged
and causes a quicker bellow collapse which simulates a
stiffer lung.
The realized device is also applicable to test further ven-
tilator features: in fact, a widely utilized diagnostic tool to
identify human respiratory diseases is the shape recognition
of the pressurevolume loop PV loop and owvolume
loop FV loop generated by the patient during forced res-
piration. Moreover, automatic shape recognition systems
have been recently developed
39
also by means of neural net-
work algorithms in order to support medical diagnosis. For
these reasons, the proposed simulator was designed to be
effectively used to plot PV and FV loops according to the
characteristics of a chosen pathology by means of an ad-
equate regulation of OS percentage and variations. Figure 6
shows PV loops produced by varying the aforementioned
two parameters. Curves a, b, c, and d1 were obtained with
100%, 60%, 30%, and 0% OS respectively, corresponding to
pulmonary compliances equal to 5.6, 4.2, 3.6, and 2.3 ml/kPa
0.55, 0.41, 0.35, and 0.23 ml/cm H
2
O. Curves d1 and d2
instead were obtained by modifying expiratory signal via
software setting equal to 140 ms and 50 ms, respectively:
in particular, curve d2 corresponds to 1.5 ml/kPa 0.15
ml/cm H
2
O compliance. In the clinical practice, curve a is
recognized as characteristic of respiratory functionality of a
healthy preterm infant at 8 months gestational age, while
curve d2 is called bird-shaped PV loop and indicates the
presence of the pathological condition known as NRDS, i.e.,
low volumes ventilated with strong muscular efforts due to
lung stiffening. From an analysis of curves d1 and d2, a
small compliance variation C0.8 ml/kPa 0.08 ml/cm
H
2
O, induced by a variation equal to 90 ms, produces two
easily distinguishable PV loops that, being digitized and
stored, can also be analyzed by an automatic pattern recog-
nition system. As a result, the lowest compliance value the
TABLE I. Comparison of the performances of realized device Tester A to those of a commercially available tester for pulmonary ventilators Tester B.
Tester A Tester B
Intended use neonatal, for premature infants for adults, pediatric, and neonatal
Respiratory frequency 40200 bpm 10150 bpm
Compliance C 1.55.9 ml/kPa 0.150.60 ml/cm H
2
O 101529 ml/kPa 1150 ml/cm H
2
O
Compliance accuracy 0.5 ml/kPa 0.05 ml/cm H
2
O unknown
Time constant 50300 ms unknown
Resistance R 629 kPa s l
1
60300 cm H
2
O s l
1
) 0.5, 2.0, 4.9, 19.6, and 49.1 kPa s l
1
5, 20, 50, 200, and 500 cm
H
2
O s l
1
)
Resistance accuracy dependent on C and accuracies unknown
Tidal volume 27 ml 52000 ml
Tidal volume standard deviation 1% unknown
FIG. 5. Simulated compliance vs OS percentage tests results. is standard
deviation associated to OS% acceptable values.
FIG. 6. PV loops obtained by varying OS percentage span and expiratory
. Curves a, b, c, and d1 correspond to 100%, 60%, 30%, and 0% OS, curves
d1 and d2 correspond to 140 ms and 50 ms and 0% OS.
2415 Rev. Sci. Instrum., Vol. 73, No. 6, June 2002 Active neonatal breathing simulator
proposed system is able to simulate is 1.5 ml/kPa 0.15
ml/cm H
2
O.
In consideration of the herein determined simulator per-
formances, once the pathology to simulate is chosen and
both the breathing mechanical parameters and the values for
the described regulations are specied individually, the pul-
monary simulator generates a respiratory pattern by repeat-
ing the wave form synthesized according to time parameters
set by the operator and continuously measures the delivered
volume. Before proceeding with the test, a preliminary cali-
bration procedure is then actuated for up to 5 min while
software routines continuously compare the measured vol-
ume signal to the one set, and automatically adjust software
coefcients until the difference between measured and set
values is less than 1%, i.e., an accuracy of 0.05 ml in corre-
spondence to a volume peak value of about 5 ml.
As previously mentioned, the simulated airway resis-
tance is unequivocally determined once and C are set and it
can range from 6 to 29 kPa s l
1
60 to 300 cm H
2
O s l
1
, in
correspondence to and C variations in the range from 50 to
300 ms and from 1.5 to 5.9 ml/kPa 0.15 to 0.60 ml/cm
H
2
O, respectively.
In Table I are reported the performances of the realized
prototype Tester A compared to those of a widely
11,12
uti-
lized reference tester for pulmonary ventilators Tester B.
From an analysis of the data reported in Table I, it is possible
to observe that a reduction of the limits of utilization of the
proposed device determines an accuracy increase of the
simulated mechanical parameters. In particular, low compli-
ance values can be obtained only by means of novel design
of the pulmonary ventilator tester, specically intended for
neonatal utilization. Moreover, whereas resistance variations
are obtained in tester B by manual substitution of a tube
representing the AT, the proposed tester A is able to change
the working characteristic by means of the variation of me-
chanical parameter values, performed almost exclusively via
software by the choice of and C. The use of a stepper motor
coupled with the axial rod for the continuous regulation of
the OS percentage will then be examined in the ongoing
research phase. Finally, the possibility of simulating apnea
periods, sighs, coughs, etc., can easily be implemented in the
proposed simulator by means of the control software, in or-
der to reproduce, in a more realistic way, the mechanical
behavior of infant respiratory apparatus in physiopathologi-
cal conditions.
ACKNOWLEDGMENTS
The authors wish to thank Professor Francesco Paolo
Branca for providing suggestions and Rocco Conti for assist-
ing with experimental tests. They express their appreciation
to the Clinical Engineering Service of the Childrens Hospi-
tal Bambino Gesu
`
of Rome for the experimental facilities
provided.
1
Despite the fact that the International Unit for pressure is pascal, due to
the examined topic that mainly concerns medical applications, we have
chosen to report pressure values also in cm H
2
O centimeters of water in
order to allow the immediate comparison of the obtained results with
those reported in scientic medical literature where this old unit is still
widely used.
2
Le Systeme International dUnites (SI) The International System of Units
SI, 6th ed. Bur. Intl. Poids et Mesures, Svres, France, 1991.
3
Natl. Inst. Stand. Technol. Spec. Publ. 330, 1991 Edition, The Interna-
tional System of Units SI, edited by B. N. Taylor U.S. Government
Printing Ofce, Washington, 1991.
4
ISO 1000:1992, SI units and recommendations for the use of their mul-
tiples and of certain other units, International Organization for Standard-
ization, Geneva, Switzerland, 1992.
5
M. Hauschild et al., Klin. Padiatr. 206, 167 1994 in German.
6
A. R. Stark et al., J. Pediatr. St. Louis 94, 439 1979.
7
A. Greenough et al., J. Pediatr. St. Louis 103, 769 1983.
8
S. K. Pingleton, Am. Rev. Respir. Dis. 137, 1463 1988.
9
D. Dreyfuss et al., Am. Rev. Respir. Dis. 137, 1159 1988.
10
D. Dreyfuss and G. Saumon, Am. J. Resp. Crit. Care Med. 157, 294
1998.
11
L. F. Samodelov and K. J. Falke, Intensive Care Med. 14, 632 1988.
12
Y. A. Konyukov et al., Intensive Care Med. 22, 363 1996.
13
T. Takahashi et al., Chest 100, 1030 1991.
14
M. Nishimura, D. Hess, and M. Kacmarek, Am. J. Resp. Crit. Care Med.
152, 1901 1995.
15
G. S. H. Sassoon, and S. E. Cruer, Intensive Care Med. 21, 159 1995.
16
G. Belforte et al., Measurement 27, 241 2000.
17
Commercially available infant lung simulators allow the user to set com-
pliances in the range 10204 ml/kPa 120 ml/cm H
2
O and this setting is
usually step variable. Step resolution varies depending on the manufac-
turer; our survey outlined an average resolution of about 51 ml/kPa 5
ml/cm H
2
O. In most cases, manufacturers do not even guarantee the
resolution at very low compliances and do not specify, for instance, the
associated accuracy; moreover the devices intended for infant use are not
suitable for preterm infants.
18
ISO 10651-1.
19
ASTM F1100, Ventilators for use during critical care.
20
ASTM F920, Resuscitators for use with humans.
21
T. Hansen and A. Corbet, in Disease of the Newborn, 7th ed., edited by H.
W. Taeusch, R. A. Ballard, and M. E. Avery Saunders, Philadelphia,
1998, pp. 634643.
22
A. Greenough, C. J. Morley, and N. R. C. Robertson, in Textbook of
Neonatology, edited by N. R. C. Robertson Churchill Livingstone, Edin-
burgh, 1991, pp. 385486.
23
The lower value, i.e., 1 ml/kPa 0.1 ml/cm H
2
O, is reached in case of
respiratory distress syndrome RDS, frequent in premature infants.
24
The higher value of 15 kPa s l
1
150 cm H
2
O s l
1
) is typical of BPD.
25
0200 Hz bandwidth and 80 dB/dec.
26
J. R. Ligas and F. P. Primiano, in Encyclopedia of Medical Devices and
Instrumentation, edited by J. G. Webster Wiley, New York, 1988, pp.
25502573.
27
Compliance and volume are respectively equal to 6.00.5 ml/kPa 0.60
0.05 ml/cm H
2
O and about 40 ml. This volume value, that is higher
than one specic for the lungs of a neonatal patient, is not relevant to the
simulator performance: in fact, its functioning only depends on the current
compliance, resistance, tidal volume, that is on the order of 4 ml, ow, and
pressure values.
28
E. Calzia et al., Intensive Care Med. 24, 931 1998.
29
Measuring range 2.5 kPa 25 cm H
2
O, overall accuracy 50 Pa
0.5 cm H
2
O.
30
Measuring range 4200 ml/s, overall accuracy 1.5 ml/s.
31
12 m diameter of platinum wires, 2.4 mm wire length, velocity range
0.210.0 m/s, and overall accuracy 0.1 m/s.
32
1030 ml/s corresponding to a delivered air volume per minute of 0.20.8
l/min in the range of breathing frequency from 20 to 160 bpm.
33
P10 Pa s ml
1
0.1 cm H
2
O s ml
1
.
34
6.0 cm internal diameter, open in the upper side.
35
0.120.01 kg m
1
s
1
in temperature range 10 C80 C.
36
J. Mead and J. L. Whittenberger, J. Appl. Physiol. 31, 934 1971.
37
0%, orices completely closed; 100%, orices completely open.
38
ISO standards require an error less than 10%15% on simulated param-
eters.
39
S. Leonhardt et al., Control. Eng. 5, 1355 1997.
2416 Rev. Sci. Instrum., Vol. 73, No. 6, June 2002 Cappa, Sciuto, and Silvestri