MARCH 2006 VOLUME
3, NUMBER 7 In
this issue...
The clinical application of blood gas analysis and
pulse oximetry is regulated in the United States,
with new guidelines enforcing the use of these technologies
to monitor the baby in the delivery room and special
care nursery. To date, the practice of delivery room
resuscitation of the newborn in the United States
has varied widely, with pulse oximetry gaining in
popularity. However, the data used by the manufacturers
of these technologies relies on test reagents, adult
data, and controlled environments; indeed, every effort
is taken by these technology manufacturers to isolate
and limit variables in order to develop steady-state
conditions during which reference data is collected.
Unfortunately, the environs of caring for the sick
newborn and physiological aspects unique to the infant
make for circumstances less conducive to accurate
data acquisition. To that point, a recent report of
clinical use found the accuracy of pulse oximetry
SpO2 values in neonates was appreciably
worse than manufacturers’ claims.
In this issue, we review the current literature describing
how manufacturers establish instrument accuracy, examine
factors that can degrade accuracy, and provide tools
for maximizing blood gas analysis and pulse oximetry
performance in neonatal care.
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Commentary
& Reviews:
Robert J. Kopotic,
MSN, RRT, FAARC
Director of Clinical Programs
ConMed Corporation
Vital Signs Development Center |
Guest Faculty Disclosure:
Robert J. Kopotic
Faculty Disclosure: Has indicated a financial
relationship with the ConMed Corporation.
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on off label products.
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Course
Directors
Edward E, Lawson, M.D.
Professor
Department of Pediatrics Neonatalogy
The Johns Hopkins University
School of Medicine
Lawrence M. Nogee, M.D.
Associate Professor
Department of Pediatrics Neonatalogy
The Johns Hopkins University
School of Medicine
Christoph U. Lehmann, M.D.
Assistant Professor
Department of Pediatrics,
Health Information
Science and Dermatology
The Johns Hopkins University
School of Medicine
Mary Terhaar, RN
Assistant Professor
Undergraduate Instruction,
The Johns Hopkins University
School of Nursing
Robert J. Kopotic, MSN,
RRT, FAARC
Director of Clinical Programs
ConMed Corporation
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Expiration Date
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Next Issue
April 15, 2006
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Commentary |
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A long established measure of the degree and duration of
fetal hypoxia has been blood pH, drawn either from the scalp
or the cord, a practice carried into newborn care with pH
analysis of heel puncture blood. Because of the stability
of this value, factors such as the length of sampling time,
the degree of exposure to air, and mixing of blood sources
(arteriolar, capillary and venous) have little affect on measurement
accuracy. However, of relevance to the topic at hand, blood
gases (PaO2 and PaCO2), blood CO-oximetry
(SaO2), and pulse oximetry (SpO2 and
pulse rate) values are highly volatile in neonates and affected
by many variables. In addition, blood analyzers are technically
sophisticated devices, requiring a great degree of skilled
maintenance to be kept in optimal working order. Conversely,
a pulse oximeter requires little sophistication to operate,
and the typical sensor is quite intuitive to place. Pulse
oximetry is largely trouble-free, and requires minor user
interface (other than the occasional changing of the sensor
site). Perhaps the simple nature of pulse oximeter operation
is cause for the lack of end-user understanding and results
in badly interpreted data.1-4
The clinical application of blood gas analysis (BGA) and
pulse oximetry (PO) is regulated in the United States by the
Joint Commission on Accreditation of Healthcare Organizations
(JCAHO). However, JCAHO requires compliance with the guidelines
of other groups, primarily the Clinical and Laboratory Standards
Institute (CLSI) and its predecessor NCCLS, prior to accrediting
an institution. Relevant to this discussion, these guidelines
focus on measurement via analytical instruments, such as analyzers
for measurement of blood CO-oximetry, gas and pH.5-8
These guideline documents primarily describe principles for
collecting, handling, transporting, and analyzing arterial
blood specimens, as well as instrument quality control matters,
with the aims of reducing collection hazards, ensuring integrity
of the arterial specimen, and achieving reliable data.
The standards emphasize that PO SpO2 values are
not a direct measure of the percent of arterial hemoglobin
saturated with oxygen.9-11 The current pulse
oximeters in neonatal use cannot differentiate nor quantify
dyshemoglobins. It is important to note that the calculated
SaO2 value reported via a blood gas analyzer
is not a reference for SpO2. Rather, only
the functional SaO2 value from CO-oximeter
analysis of an arterial blood specimen can provide a reference
for SpO2. The CO-oximeter also provides a measure
of the content of fetal versus adult hemoglobin. Table 1
reviews the user interventions and rationale associated
with optimizing accuracy in comparing SaO2 and
SpO2 values in neonates.
Download
Optimizing comparison of a CO-oximetry SaO2 value with pulse
oximetry (PO) SpO2 values in neonates.
The accuracy of PO SpO2 values is derived by testing
healthy adult human volunteers under controlled laboratory
conditions (CLC). In CLC, every effort is taken to isolate
and limit variables, and to seek steady-state conditions during
which reference data can be synchronized. In the NICU, when
the infant is the least stable, concurrence of BGA and PO
data is most desired and expected. Table 2 details why the
NICU environment is less conducive to accurate data acquisition
than the CLC used by PO manufacturers. It is safe to assume
that in contrast to the NICU, the collection of this data
in the delivery room setting would be far more difficult and
prone to patient and caregiver variables.
Download
Comparing SaO2 to
SpO2 data in an NICU versus that from controlled
laboratory conditions.
Note: Author Comments in Parentheses
New guidelines for neonatal resuscitation have been promulgated.12
Care of the sick newborn requires the best instrumentation
complemented by thorough clinical vigilance. Pulse oximetry
data derived immediately post-delivery have prompted comparative
interventional studies.13 Lack of PO was a contributing
factor of poor outcome during infant sedation.14
Some have suggested close-looping SpO2 values to
maintain normoxemia in mechanically ventilated infants.15,16
With this degree of reliance on basic and advanced newborn
care, PO accuracy is essential. Unfortunately, in clinical
use, the accuracy of SpO2 values in neonates was
found appreciably worse than manufacturers’ claims.
Caregivers should recognize multiple sources of compounding
error in the clinical setting that can corrupt correlation
of SaO2 to SpO2 values versus the claimed
accuracy data of PO manufacturers. There is dissimilarity
in populations (the ill neonate versus healthy adult) and
an SpO2 plateau at the time of blood sampling may
not occur in the NICU, whereas SpO2 plateaus are
an expectation in the laboratory setting. Without controlling
such influences, comparison between blood analysis and pulse
oximetry values is fraught with error and the potential for
misinterpretation. Owing to an avoidance of invasive risk,
SpO2 data are often relied upon in conditions where
direct arterial access for corroboration of SpO2
values does not exist, so the data go unchecked.
At the moment, it appears that while pulse oximetry is
included in the updated resuscitation guidelines, clinical
use data reveal oximeters currently used in neonatal care
can lack the precision claims of their manufacturers. Given
that, caution may be warranted in using pulse oximetry for
a discrete value of SpO2. Rather, a trend of
stability or declining and increasing SpO2 values
may prove more beneficial to clinical care. Suggestions
and rationale for optimizing blood gas and pulse oximetry
data were included in this review to provide a common denominator
for future comparative studies and maximize accuracy in
the assessment of oxygenation in the acute care of newborns.
References:
1. |
Popovich DM, Richiuso N,
Danek G. Pediatric
health care providers' knowledge of pulse oximetry.
Pediatr Nurs 2004;30:14-20. |
2. |
Teoh L, Epstein A, Williamson
B, Morton J, Papadopoulos D, Teng A. Medical
staff's knowledge of pulse oximetry: a prospective survey
conducted in a tertiary children's hospital. J
Paediatr Child Health 2003;39(8):618-622. |
3. |
Rodriguez LR, Kotin N,
Lowenthal D, Kattan M. A
study of pediatric house staff’s knowledge of pulse
oximetry. Pediatr 1994;93(5):810-813. |
4. |
Stoneham MD, Saville GM,
Wilson IH. Knowledge
about pulse oximetry among medical and nursing staff.
Lancet 1994;344(8933):1339-1342. |
5. |
NCCLS Document C46-A. Blood
Gas and pH Analysis and Related Measurements; Approved
Guideline. NCCLS Wayne, PA 2001. |
6. |
NCCLS Document H11-A3.
Procedures
for the Collection of Arterial Blood Specimens;
Approved Standard. NCCLS Wayne, PA 1999. |
7. |
NCCLS Document C25-A. Fractional
Oxyhaemoglobin, Oxygen Content and Saturation, and Related
Quantities in Blood: Terminology, Measurement, and Reporting;
Approved Guideline. NCCLS Wayne, PA 1997. |
8. |
AARC. Clinical
Practice Guideline: blood gas analysis and hemoximetry.
Respir Care 2001;46:498-505. |
9. |
AARC
Clinical Practice Guideline: Pulse oximetry. Respir
Care 1991;36(12):1406-1409. |
10. |
CLSI Document HS3-A. Pulse
Oximetry; Approved Guideline. CLSI Wayne, PA
2005. |
11. |
ISO 9919:2005, Medical
electrical equipment - Particular requirements
for the basic safety and essential performance of pulse
oximeter equipment for medical use. CEN WI 00215098
- CEN/TC 215 (publication of the ASTM F29.11.05 and ISO
TC 121 SC3 working group on pulse oximeters). Geneva,
CH (2005-03-15). |
12. |
O’Keefe L. Academy
adopts resuscitation guidelines. AAP News March
2006, p 38. |
13. |
Kopotic RJ, Lindner W.
Assessing
high-risk infants in the delivery room with pulse oximetry.
Anesth Analg 2002;94(S1):S31-66. |
14. |
Cote CJ, Notterman DA,
Karl HW, Weinberg JA, McCloskey C. Adverse
sedation events in pediatrics: a critical incident analysis
of contributing factors. Pediatr 2000;105(4):805-814. |
15. |
Urschitz MS, Von Einem
V, Seyfang A, Poets CF. Use
of pulse oximetry in automated oxygen delivery to ventilated
infants. Anesth Analg 2002;82(1S):37-40. |
16. |
Claure N, Gerhardt T, Everett
R, Musante G, Herrera C, Bancalari E. Closed-loop
controlled inspired oxygen concentration for mechanically
ventilated very low birth weight infants with frequent
episodes of hypoxemia. Pediatr 2001;107(5):1120-1124. |
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UPDATED
GUIDELINES FOR RESUSCITATING THE NEONATE |
Article
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View
journal abstract |
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full article |
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International
Liaison Committee on Resuscitation.
Part 13: Neonatal resuscitation guidelines.
Circulation 2005:112(24, suppl):IV188-IV195.
(For non-journal subscribers,
an additional fee may apply for full text articles) |
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The AAP News, the official newsmagazine of the American Academy
of Pediatrics, recently reported that the AAP has adopted
new guidelines for resuscitating neonates and will publish
them in the May 2006 issue of the journal Pediatrics12.
These revised guidelines, based on the 2005 American Heart
Association Guidelines for Cardiopulmonary Resuscitation and
Emergency Cardiovascular Care, suggest the use of pulse oximetry
in the periodic evaluation at 30-second intervals. They stress
that the normal newborn may take >10 minutes for post-ductal
SpO2 values to reach 95%. Several paragraphs discuss
room-air resuscitation versus 100% oxygen and note that: “Administration
of a variable concentration of oxygen guided by pulse oximetry
may improve the ability to achieve normoxia more quickly.”
Additional recommendations include advising facilities that
electively deliver babies at less than 32 weeks' gestation
to provide both oxygen blenders and pulse oximeters in delivery
rooms. They also recommend starting mechanical ventilation
with room air-diluted oxygen; the level should be adjusted
up or down until oxyhemoglobin concentration increases to
near 90%. (Practitioners should note that oxyhemoglobin is
measured directly via CO-oximetry of arterial blood and estimated
with the SpO2 displayed by a pulse oximeter.)
The guidelines are based on a review of the latest scientific
evidence, and affirm assessment of oxygenation status and
management of supplemental oxygen therapy via pulse oximetry.
Lacking, however, is specificity for resuscitation with
airway concentrations of 100% oxygen or less, as well as
adequate caution regarding the subjectivity of pulse oximetry
data, and the need for performance optimization in the resuscitation
setting (where challenges to instrument accuracy can be
extreme).
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VARYING
U.S. PRACTICES OF RESUSCITATING THE NEWBORN POST DELIVERY |
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Leone
TA, Rich W, Finer NN.
A survey of delivery room resuscitation practices
in the United States.
Pediatrics 2006(2);117:164-175.
(For non-journal subscribers,
an additional fee may apply for full text articles)
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This study addressed delivery room resuscitation practices
in the United States with the aim of determining the extent
of variation among neonatal programs. In 2004, the authors
designed a 15-question survey about resuscitation staff, tools,
and techniques. It was mailed to 795 neonatal directors; 450
surveys were completed (response rate of 63%), representing
all 50 States.
The authors captured a snapshot of current NRP practices
across the Unites States. Among their results, pertinent
to the subject of this review, is that 52% of program directors
used pulse oximetry, with 23% indicated that they had useful
readings within 1 minute of placing a sensor. The authors
remark that while the time to data acquisition may vary,
pulse oximetry is useful for monitoring subsequent care
of infants and is essential if clinicians wish to use a
blender and to provide <100% oxygen. They further comment
that their experience in evaluating neonatal resuscitation
suggests that infants spend far more time in the resuscitation
area than is anticipated, and the use of blenders and oximeters
in such circumstances can reduce unnecessary exposure to
excessive supplemental oxygen. While they suggest that in
the delivery room the oximeter should be set to its lowest
averaging time and highest sensitivity, the rationale and
consequences of such settings are not discussed. Moreover,
the shortcomings of pulse oximetry are not mentioned nor
is reference made to means of reducing error.
The authors conclude that substantial variations exist
in neonatal resuscitation practices, some of which are not
addressed in existing guidelines. They recommend that future
guidelines include the use of blenders, oximeters, continuous
positive airway pressure/PEEP, and plastic wrap during resuscitation.
Further, the authors express their hope that the widespread
dissemination of these survey results will encourage re-evaluations
of practice efficacy, so that future resuscitation practices
will be evidence based.
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DO
NEONATAL SpO2 VALUES CORRELATE WITH MEASURED ARTERIAL SATURATION? |
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Gerstmann
D, Berg R, Haskell R, et al.
Operational evaluation of pulse oximetry in NICU patients
with arterial access. Journal of Perinatology 2003;23(5):378-383.
(For non-journal subscribers,
an additional fee may apply for full text articles)
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This wide-ranging study by Gerstmann et al sought to analyze
available data recorded during the process of providing
routine neonatal care. They performed a historical evaluation,
a prospective evaluation, a procedural evaluation, a verification
evaluation, and an evaluation of corroborating data from
NICUs at several institutions.
Of particular note is their determination that a calculated
SaO2 via a blood gas analyzer was not appropriate
for comparing SpO2 accuracy; rather, they measured
functional SaO2 with the corresponding pre-blood draw baseline
SpO2. Multiple brands of CO-oximeters (ABL, Beyer,
and Instrumentation Laboratory) and pulse oximeters (Datex-Ohmeda,
Masimo, Nellcor and Spacelabs) were used. In order to contrast
the neonatal performance of the models of pulse oximeter
for which data were available, operational performance was
defined as the frequency with which, at any given SaO2 value,
the corresponding SpO2 reading was within a manufacturer’s
specified accuracy for neonates (typically, ±3 digits
(1 SD) between 70% and 100% saturation).
Nearly 32 thousand data sets of SaO2 to SpO2
values collected during routine care were compared. While
the range of SaO2 was from 57% to 100%, most
data were between 85% to 100%. As a point of measurement
consistency between the two brands of CO-oximeters, 52 arterial
blood samples were drawn from 10 neonates and run simultaneously
on both CO-oximeters. The average difference in SaO2 values
was 0.07, which proved to be not statistically significant.
However, none of the pulse oximeters provided a consistent
bias of SpO2 values across the range of SaO2
of 70% to 100%. While SpO2 accuracy was device
dependant between an SaO2 of 92% to 97%, performance declined
for all manufacturers above and below this range. Indeed,
a rapid drop in operational performance was seen in all
pulse oximeters as SaO2 decreased. As an example,
at an SaO2 of 80%, SpO2 will typically read approximately
90%.
This study is the largest collection of neonatal data comparing
SaO2 and SpO2 values. Notably, the
period of data collection was nearly concurrent with the
survey of neonatal directors by Leone et al (as above).
Gerstmann et al suggest that the poor SpO2 accuracy
seen in their data seems at a level inconsistent with pulse
oximetry’s perceived importance, role and use in the
NICU. Elaborating on the results, concerns of both over-
and under- treatment were raised. They conclude, pending
improvement in SpO2 accuracy, that adjustments
to supplemental oxygen and ventilator settings in the NICU
patient “must be based on and re-evaluated by arterial
blood analysis.” Further, the authors demonstrated
that some variables were not evident, e.g. the difference
in CO-oximeter brand.
It must be noted that while the multi-center, multi-caregiver
design of this study doubtless introduced inconsistencies,
those inconsistencies accurately replicate the environment
typical to the daily care of neonates in centers across
the Nation.
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LAST
MONTH�S Q & A March 2006 - Volume 3 -
Issue 7
Last
issue we reviewed the clinical application of blood gas
analysis and pulse oximetry, discussed the new guidelines
enforcing the use of these technologies, and compared PO
manufacturers' accuracy claims vs the reality of caring
for the sick newborn.
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Commentary
& Reviews:
Robert J. Kopotic, MSN, RRT,
FAARC
Director of Clinical Programs
ConMed Corporation
Vital Signs Development Center |
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We
received the following questions one of our subscribers. |
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Regarding
the limitations of pulse oximetry technology: although
we strive for a reliability value ±3%, we are
still unclear on what our target saturations should
be. Can you provide more clarification on this topic? |
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The
purpose of this review was to caution endusers on the
shortcomings of blood analysis and pulse oximetry with
a focus of optimizing their accuracy. Target SpO2
values in neonatal care are a different matter, and
are the subject of on-going investigation. Following
are links to several recent papers on the subject, which
should prove of interest.
Cole CH, Wright KW, Tarnow-Mordi W, Phelps DL; Pulse
Oximetry Saturation Trial for Prevention of Retinopathy
of Prematurity Planning Study Group. Resolving
our uncertainty about oxygen therapy. Pediatrics.
2003 Dec;112(6 Pt 1):1415-9.
Lloyd J, Askie L, Smith J, Tarnow-Mordi W. Supplemental
oxygen for the treatment of prethreshold retinopathy
of prematurity. Cochrane Database Syst Rev. 2003;(2):CD003482.
Review.
Saugstad OD. Optimal
oxygen therapy in the newborn period. Pediatr
Pulmonol Suppl. 2004;26:112-3. |
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The
eNeonatal Review Team asked the March faculty a few
questions. |
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Given
the degree of caution raised in the Gerstmann et al
paper (e.g., "use of the pulse oximeters tested
could lead to over treatment...and...a neonate could
be under treated"), is there a place for pulse
oximetry in neonatal care? |
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Perhaps
pulse oximetry’s greatest contribution to neonatal
monitoring is as an indicator of the trend of oxygenation,
and not a measure of absolute SaO2 values.
Consequently, it is essential that endusers understand,
identify, and (hopefully) avoid blood components or
external factors that may cause sustained erroneous
SpO2 readings. |
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Of
the two blood oxygenation extremes (i.e., hyper- and
hypoxemia), what is the role of SaO2 versus
SpO2 monitoring? |
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Numerous
publications have warned that hyperoxemia is not well
assessed with pulse oximetry, but observing trends
of SpO2 can be a helpful means of avoiding
hypoxemia. However, monitoring blood specimens from
direct arterial access for SaO2 and/or
PaO2 values can be useful for managing
either extreme.
Baeckert P, Bucher HU, Fallenstein F, Fanconi S,
Huch R, Duc G. Is
pulse oximetry reliable in detecting hyperoxemia in
the neonate? Adv Exp Med Biol 1987;220:165-169.
Beresford MW, Parry H, Shaw NJ. Twelve-month
prospective study of oxygen saturation measurements
among term and preterm infants. J Perinatol. 2005
Jan;25(1):30-2.
Poets CF, Wilken M, Seidenberg J, Southall DP, von
der Hardt H. The
reliability of a pulse oximeter in the detection of
hyperoxemia. J Pediatr 1993;122:87-90. |
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This activity has been developed for Neonatologists,
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At the conclusion of this activity, participants should
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- Discuss the new guidelines for resuscitating neonates and
the current lack of uniformity in resuscitation practices in
the United States.
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analysis and pulse oximetry instrumentation.
- Describe, as they specifically relate to neonatal care, the
issues that challenge the accuracy of blood gas analysis and
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