Critical Care Medical Accuracy of a continuous noninvasive hemoglobin monitor in intensive care unit patients.

Article Summary and PowerPoint Presentations:The assigned article is attached as a file and you are to review, summarize, and present to the class. You are required to prepare a PowerPoint presentation that summarizes the assigned article. In addition, you will write a one-page summary of the article. Thus you are required to submit your PowerPoint presentation and a one page written summary, including any special graphics in this assignment. Instructions for PowerPoint PresentationsThe Journal Citation in APA format: Authors, Title, Journal Name, Volume, Year, Page NumbersPurpose Statement/ Hypothesis: single sentence (no more than two sentences) Methods: Give enough info so we understand in general what was doneResults: Bullets in brief or the results. If graphics or tables are key to understanding the results, then identify them. You are encouraged to identify key graphics that are likely to be the foundation for exam questionsConclusions: These should be in statements identifying the major findings of the paper.PowerPoint Slide Presentation: This part should be a slide presentation of the elements above (Should be not more than 9 slides). Each slide is worth a possible 10 points.Slide#1 – Must include the Journal Citation (use APA format), the course, the date you are presenting and your name.Slide#2 – Purpose statement/hypothesis or what the authors were trying to determine or demonstrateSlide#3 – Methods Section: one slide; try to keep this as simple and explanatory as possibleSlide#4 -6 Results and Figures: This will consist of each of the major findings and two tables or graphs that demonstrate these findings. Slide#7 – Conclusion.Slide#8-9 – Two sample exam questions for the class to ponder –try to challenge them to see if they understand the results or if they can explain the graphics.Note: Please find attached the Article.
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Presentations:
The assigned article is attached as a file and you are to review, summarize, and present to the class.
You are required to prepare a PowerPoint presentation that summarizes the assigned article. In
addition, you will write a one-page summary of the article. Thus you are required to submit your
PowerPoint presentation and a one page written summary, including any special graphics in this
assignment.
Instructions for PowerPoint Presentations
•
•
•
•
•
The Journal Citation in APA format: Authors, Title, Journal Name, Volume, Year, Page Numbers
Purpose Statement/ Hypothesis: single sentence (no more than two sentences)
Methods: Give enough info so we understand in general what was done
Results: Bullets in brief or the results. If graphics or tables are key to understanding the results,
then identify them. You are encouraged to identify key graphics that are likely to be the foundation
for exam questions
Conclusions: These should be in statements identifying the major findings of the paper.
PowerPoint Slide Presentation:
This part should be a slide presentation of the elements above (Should be not more than 9 slides).
Each slide is worth a possible 10 points.
Slide#1 – Must include the Journal Citation (use APA format), the course, the date you are
presenting and your name.
Slide#2 – Purpose statement/hypothesis or what the authors were trying to determine or
demonstrate
Slide#3 – Methods Section: one slide; try to keep this as simple and explanatory as possible
Slide#4 -6 Results and Figures: This will consist of each of the major findings and two tables or
graphs that demonstrate these findings.
Slide#7 – Conclusion.
Slide#8-9 – Two sample exam questions for the class to ponder –try to challenge them to see if they
understand the results or if they can explain the graphics.
Article Summary and PowerPoint Presentations:
The assigned article is attached as a file and you are to review, summarize, and present to the class.
You are required to prepare a PowerPoint presentation that summarizes the assigned article. In
addition, you will write a one-page summary of the article. Thus you are required to submit your
PowerPoint presentation and a one page written summary, including any special graphics in this
assignment.
Instructions for PowerPoint Presentations
•
•
•
•
•
The Journal Citation in APA format: Authors, Title, Journal Name, Volume, Year, Page Numbers
Purpose Statement/ Hypothesis: single sentence (no more than two sentences)
Methods: Give enough info so we understand in general what was done
Results: Bullets in brief or the results. If graphics or tables are key to understanding the results,
then identify them. You are encouraged to identify key graphics that are likely to be the foundation
for exam questions
Conclusions: These should be in statements identifying the major findings of the paper.
PowerPoint Slide Presentation:
This part should be a slide presentation of the elements above (Should be not more than 9 slides).
Each slide is worth a possible 10 points.
Slide#1 – Must include the Journal Citation (use APA format), the course, the date you are
presenting and your name.
Slide#2 – Purpose statement/hypothesis or what the authors were trying to determine or
demonstrate
Slide#3 – Methods Section: one slide; try to keep this as simple and explanatory as possible
Slide#4 -6 Results and Figures: This will consist of each of the major findings and two tables or
graphs that demonstrate these findings.
Slide#7 – Conclusion.
Slide#8-9 – Two sample exam questions for the class to ponder –try to challenge them to see if they
understand the results or if they can explain the graphics.
Note: Please find attached the Article.
Accuracy of a continuous noninvasive hemoglobin monitor in
intensive care unit patients*
Denis Frasca, MD; Claire Dahyot-Fizelier, PhD; Karen Catherine, MD; Quentin Levrat, MD;
Bertrand Debaene, MD; Olivier Mimoz, PhD
Objective: To determine whether noninvasive hemoglobin measurement by Pulse CO-Oximetry could provide clinically acceptable
absolute and trend accuracy in critically ill patients, compared to
other invasive methods of hemoglobin assessment available at bedside and the gold standard, the laboratory analyzer.
Design: Prospective study.
Setting: Surgical intensive care unit of a university teaching
hospital.
Patients: Sixty-two patients continuously monitored with Pulse
CO-Oximetry (Masimo Radical-7).
Interventions: None.
Measurements and Results: Four hundred seventy-one blood
samples were analyzed by a point-of-care device (HemoCue 301),
a satellite lab CO-Oximeter (Siemens RapidPoint 405), and a
laboratory hematology analyzer (Sysmex XT-2000i), which was
considered the reference device. Hemoglobin values reported
from the invasive methods were compared to the values reported
by the Pulse CO-Oximeter at the time of blood draw. When the
A
nemia is a common complication seen in intensive care unit
(ICU) patients (1– 6). Its diagnosis cannot be validated clinically, and historically has required confirmation through laboratory analysis of a
patient blood sample. In the United
States, invasive hemoglobin measurement is performed over 400 million times
per year (4). Blood loss from phlebotomy
causes iatrogenic anemia, with over 90%
*See also p. 2369.
From the Centre Hospitalier Universitaire de Poitiers (DF, CDF, KC, QL, BD, OM), INSERM ERI 23 (DF,
CDF, BD, OM), and Universite´ de Poitiers, UFR de
Me´decine-Pharmacie (DF, CDF, BD, OM), Poitiers,
France.
Supported, in part, by Masimo, who supplied the
Radical-7 monitors and the sensors used for SpHb
measurement. The manufacturer had no input into the
design or conduct of this study or in the decision to
submit the manuscript for publication.
The authors have not disclosed any potential conflicts of interest.
For information regarding this article, E-mail:
o.mimoz@chu-poitiers.fr
Copyright © 2011 by the Society of Critical Care
Medicine and Lippincott Williams & Wilkins
DOI: 10.1097/CCM.0b013e3182227e2d
Crit Care Med 2011 Vol. 39, No. 10
case-to-case variation was assessed, the bias and limits of
agreement were 0.0 ? 1.0 g/dL for the Pulse CO-Oximeter, 0.3 ?
1.3g/dL for the point-of-care device, and 0.9 ? 0.6 g/dL for the
satellite lab CO-Oximeter compared to the reference method.
Pulse CO-Oximetry showed similar trend accuracy as satellite lab
CO-Oximetry, whereas the point-of-care device did not appear to
follow the trend of the laboratory analyzer as well as the other
test devices.
Conclusion: When compared to laboratory reference values,
hemoglobin measurement with Pulse CO-Oximetry has absolute
accuracy and trending accuracy similar to widely used, invasive
methods of hemoglobin measurement at bedside. Hemoglobin
measurement with pulse CO-Oximetry has the additional advantages of providing continuous measurements, noninvasively,
which may facilitate hemoglobin monitoring in the intensive care
unit. (Crit Care Med 2011; 39:2277–2282)
KEY WORDS: anemia; blood transfusion; hemoglobinometry
methods; intensive care; monitoring; point-of-care
of ICU patients becoming anemic by the
third day of ICU admission (6).
The method of reference for hemoglobin determination is the cyanomethemoglobin method (7), but this method is
costly and time consuming and therefore
not practical for clinical use. Laboratory
hematology analyzers that utilize the cyanomethemoglobin reaction for hemoglobin estimation are being replaced with
cyanide-free technologies that utilize sodium lauryl sulfate to determine hemoglobin concentration. These cyanide-free
hematology analyzers show excellent
agreement with those utilizing the cyanomethemoglobin method (7, 8) and
have become the de facto clinical standard for measuring hemoglobin. Other
methods of estimating hemoglobin concentration, such as CO oximeters and
point-of-care devices, are commonly used
in the hospital environment but are not
as accurate as hematology analyzers and
still require an invasive sample.
In contrast, the noninvasive Pulse COOximeter provides an immediate and
continuous estimation of hemoglobin
concentration noninvasively, and so has
the potential to improve ICU patient care.
The primary objective of this study was to
determine whether noninvasive hemoglobin measurement by Pulse CO-Oximetry could provide clinically acceptable
accuracy in an ICU setting, defined as
absolute and trend accuracy comparable
to common invasive methods of a COOximeter and a point-of-care device,
when all are compared to the clinical gold
standard, the hematology analyzer.
MATERIALS AND METHODS
This prospective, observational study was
conducted in a 15-bed surgical ICU at the
University Hospital in Poitiers, France. After
obtaining ethics committee approval and informed consent, adult patients admitted to the
ICU and in need of arterial blood draws for
standard care were enrolled in the study. Patients wore Rainbow adult resposable sensors
(R2–25, Revision E) connected to a Radical-7
Pulse CO-Oximeter, software version 7.6.0.1
(Masimo, Irvine, CA), for continuous and noninvasive measurement of total hemoglobin
(SpHb), SpO2, pulse rate, and perfusion index,
an indicator of localized perfusion. Sensors
were applied to the patient following the di-
2277
rections for use provided by the manufacturer.
This included the application of the adhesive
portion of the sensor so that the emitter and
detector were precisely aligned on the finger.
Sensors were covered with opaque shields to
prevent optical interference. The sensor position was checked before every reading and
readjusted if the adhesive portion became misaligned. For invasive measures of hemoglobin,
arterial blood was drawn into standard blood
collection tubes appropriate for the method of
analysis. Reference hemoglobin values were
obtained by analyzing arterial blood samples
at the laboratory using a Sysmex XT-2000i
automated hematology analyzer (Roche Diagnostics, Paris, France). The Sysmex analyzer
was calibrated daily according to manufacturer’s instructions and good laboratory practice.
The Sysmex XT series hematology analyzers
measure hemoglobin by colorimetry using the
cyanide-free, sodium lauryl sulfate method,
and its confidence limits provided by the manufacturer are ?0.2 g/dL. The same samples
were also analyzed with a satellite lab COOximeter (Siemens RapidPoint 405 COOximeter, Siemens, Munich, Germany) and a
point-of-care hemoglobinometer (HemoCue,
Hb201?, Ångelholm, Sweden). The Siemens
RapidPoint CO-Oximeter was calibrated daily
under the control of the central laboratory.
The HemoCue point-of-care device is factory
calibrated against the cyanomethemoglobin
method and does not require recalibration.
The Pulse CO-Oximeter is self-calibrating.
Precision of the test devices was assessed by
using patients’ blood samples (n ? 28 to 50
per each clinically meaningful level) measured
two times and expressed as coefficient of variation (CV, %). Within-day and between-day
imprecision for the satellite lab CO-Oximeter,
the HemoCue device, and the Pulse COOximeter were 1.70% and 1.83%, 2.81% and
3.11%, and 1.83% and 2.07% at low hemoglobin levels (7–10 g/dL); 2.40% and 2.21%,
2.70% and 2.92%, and 1.90% and 2.21% at
intermediate hemoglobin levels (10 –12 g/dL);
and 1.67% and 1.77%, 1.90% and 2.10%, and
1.70% and 1.99% at high hemoglobin levels
(12–15 g/dL), respectively. The corresponding
quality control specifications of the laboratory
reference method were 0.90% and 1.40% at
low hemoglobin levels, 0.94% and 1.50% at
intermediate levels, and 1.10 and 1.98%
at high hemoglobin levels. Invasive hemoglo-
bin values were compared to the noninvasive
hemoglobin values obtained at the time of the
blood draw. Patients’ characteristics, indication for ICU admission (medical or surgical),
Simplified Acute Physiology Score II (9) and
Sequential Organ Failure Assessment scores
(10) at admission, and norepinephrine use
were prospectively recorded.
Statistical Analysis
Data are reported as mean values and sd if
normally distributed and as median values and
minimum-maximum range if the distribution
is non-normal. A regression was calculated
using the Passing and Bablok procedure (11).
Laboratory assessment of hemoglobin was regarded as the gold standard, and the satellite
lab CO-Oximeter, HemoCue point-of-care device, and pulse CO-Oximeter as methods of
comparison. The concordance correlation coefficient was calculated. Agreement between
laboratory and test devices was performed as
described by Bland and Altman (12). In this
study, multiple hemoglobin measurements
per patient provided unequal numbers of replicated data in pairs. With clustered observations, adjustment is necessary, so mean bias
and limits of agreement were estimated by a
component of variance technique (13). Accuracy of each method compared to the reference method was calculated using accuracy
root mean square (ARMS) with the formula
?([mean bias]2 ? [SD]2). The ability of the
test devices to follow the trend of the changes
in hemoglobin values reported by the reference device was assessed by plotting the difference between subsequent measurements
reported by each device to the difference in
subsequent measurements reported by the reference device. Coefficient of determination (R2)
was calculated for each trend plot as a measure
of the goodness of fit of the change in values of
the test device compared to the expected change
represented by the change in values of the reference device. For two-tailed tests, a p value
lower than .05 was considered statistically significant. Ninety-five percent confidence intervals (95% CI) were calculated when required.
All data management and statistical analysis
was made with R software version 2.11.0 (R
Development Core Team, Vienna, Austria).
Table 1. Patients’ characteristics (n ? 62)
Age (years)
Sex ratio male/female, n (%)
Simplified acute physiology score II at admission
Sepsis-related organ failure assessment at admission
Admission, n (%)
Surgical emergencies
Elective surgery
Medical
2278
56 ? 20
48/14 (77/23)
46 ? 23
6?3
24 (39)
5 (8)
33 (53)
RESULTS
Of the 65 patients enrolled in the
study, three were excluded due to inability to obtain a noninvasive hemoglobin
reading with the Pulse CO-Oximeter. The
characteristics of the remaining 62 subjects are shown in Table 1. Subjects were
monitored with the device from 1 to 15
days, with a median monitoring time of 6
days.
A total of 471 samples were drawn
with an average of 8 ? 4 samples taken
per patient. Half of the measurements
were performed in sedated subjects and
160 of them (34%) in patients receiving
continuous norepinephrine at a dosage
between 0.02 and 3.00 ?g/kg/min (median 0.30 ?g/kg/min). At each time point,
a hemoglobin value was obtained for each
of the four methods. Hemoglobin ranged
from 6.6 g/dL to 14.9 g/dL (mean 10.0 ?
1.1 g/dL) on the laboratory hematology
analyzer, 6.3 g/dL to 14.9 g/dL (mean
10.0 ? 1.0 g/dL) on the Pulse COOximeter, 7.1 g/dL to 17.0 g/dL (mean
10.9 ? 1.2 g/dL) on the satellite lab COOximeter, and 6.5 g/dL to 17.2 g/dL
(mean 10.3 ? 1.3 g/dL) on the point-ofcare device.
The regression equations calculated
according to Passing and Bablok had intercepts of 0.85 (95% CI 0.79; 0.88), 0.90
(95% CI 0.80; 092), and 1.96 (95% CI
1.88; 2.04), and slopes of 0.93 (95% CI
0.89; 0.96), 1.00 (95% CI 0.98; 1.03), and
1.24 (95% CI 1.19; 1.30) for Pulse COOximeter, satellite lab CO-Oximeter, and
HemoCue point-of-care device, respectively (Fig. 1), compared to the reference
device. The corresponding concordance
correlation coefficient was equal to 0.79
(95% CI 0.76; 0.82), 0.74 (95% CI 0.72;
0.77), and 0.76 (95% CI 0.73; 0.80) for
Pulse CO-Oximeter, satellite lab COOximeter, and HemoCue point-of-care
device, respectively. Bland Altman plots
for each test analyzer compared to the
reference analyzer are depicted in Figure
2; each point represents a patient. Compared to the reference device, the bias
and limits of agreement were 0.0 ? 1.0
g/dL for the Pulse CO-Oximeter, 0.9 ?
0.6 g/dL for the satellite lab CO-Oximeter,
and 0.3 ? 1.3 g/dL for the HemoCue
point-of-care device. All three device
measurements appeared to have approximately equal bias throughout the hemoglobin range. Table 2 shows differences
between SpHb and laboratory hemoglobin according to laboratory hemoglobin
ranges. The highest accuracy (lowest
Crit Care Med 2011 Vol. 39, No. 10
?0.4 ? 2.6 g/dL for the HemoCue
point-of-care device.
The trend graphs showing the difference in consecutive hemoglobin values
reported by each test device compared to
the difference in consecutive hemoglobin
values reported by the laboratory reference device are displayed in Figure 3. The
coefficients of determination (R2) calculated from the trend differences in consecutive hemoglobin values reported by
each test device compared to the difference in consecutive hemoglobin values
reported by the laboratory reference device were 0.41 (95% CI 0.34; 0.43) for the
Pulse CO-Oximeter, 0.36 (95% CI 0.31;
0.39) for the satellite lab CO-Oximeter,
and 0.15 (95% CI 0.10; 0.21) for the
point-of-care device.
DISCUSSION
Figure 1. Passing-Bablok regression for Pulse CO-Oximetry, SpHb (A), satellite lab CO-Oximeter,
HbABG (B), and HemoCue point-of-care device, HbHC (C) vs. Laboratory Hematology Analyzer (tHb).
The solid line is line of regression and the dashed lines represent confidence interval for regression
line. The dotted line is line of identity.
Figure 2. Bland and Altman graph: Pulse CO-Oximeter, SpHb (A), satellite lab CO-Oximeter, HbABG
(B), and HemoCue, HbHC (C) vs. Laboratory Hematology Analyzer, tHb, with the bias (plain line) and
limits of agreement (dotted lines). Each point represents the bias of a single patient.
ARMS) was obtained with the Pulse COOximeter, with an ARMS of 0.8 g/dL. The
HemoCue point-of-care device and satellite lab CO-Oximeter both had similar
accuracy, with an ARMS of 1.1 g/dL. For
the subgroup of measurements (n ? 41)
performed when perfusion index was
lower than 0.5, the bias and the limits of
Crit Care Med 2011 Vol. 39, No. 10
agreement were 0.4 ? 1.4 g/dL for the
Pulse CO-Oximeter compared to the reference method. For the subgroup of measurements (n ? 79) performed in patients receiving norepinephrine infusion
over 0.2 ?g/kg/min, the bias and the
limits of agreement were ?0.1 ? 1.4
g/dL for the Pulse CO-Oximeter and
To the best of our knowledge, we report the first study comparing the performance of Pulse CO-Oximetry and two
techniques commonly used in the ICU, a
satellite lab CO-Oximeter and the
HemoCue point-of-care device, to a central laboratory device to estimate true
and dynamic changes of hemoglobin levels in ICU patients. The noninvasive Pulse
CO-Oximetry had the best accuracy as
evidenced by the highest concordance coefficient correlation and the lowest ARMS.
Neither the administration of norepinephrine nor low perfusion state influenced the accuracy of the device. Only
three patients (5%) with very poor peripheral perfusion had to be excluded because of the inability to obtain any SpHb
reading, despite careful sensor repositioning. The satellite lab CO-Oximeter
displayed the most pronounced bias (0.9
g/dL), leading to a constant overestimation of hemoglobin concentration. However, the precision of this device was better than both the Pulse CO-Oximeter and
the point-of-care device, as assessed by
the lowest agreement limits from Bland
Altman plots. The point-of-care device
displayed the most pronounced scattering of the three test devices compared to
the results of the reference method, as
demonstrated by the lowest concordance
coefficient correlation and the widest
limits of agreement from Bland Altman
plot.
The Pulse CO-Oximetry has been previously evaluated, mainly in surgical patients or healthy volunteers exposed to
hemodilution (4). Most of the studies are
not yet publish …
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