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Factors Affecting The Performance of 5 Cerebral.10 PDF
Factors Affecting The Performance of 5 Cerebral.10 PDF
Factors Affecting The Performance of 5 Cerebral.10 PDF
From the Department of Anesthesia and Perioperative Care, SeveringhausRadiometer Research Laboratories and the UCSF Hypoxia Research Laboratory, University of California at San Francisco, San Francisco, California.
Accepted for publication April 3, 2013.
Funding: Supported by funds derived from the testing of pulse oximeters,
but no manufacturer directly supported the study.
The authors declare no conflict of interest.
Reprints will not be available from the authors.
Address correspondence to Philip Bickler, MD, PhD, Sciences 255, Box 0542,
University of California, 513 Parnassus Ave., San Francisco, CA 94143-0542.
Address e-mail to bicklerp@anesthesia.ucsf.edu.
Copyright 2013 International Anesthesia Research Society
DOI: 10.1213/ANE.0b013e318297d763
measure the state of oxygen metabolism in tissues by assessing the near-infrared absorption of cytochrome C oxidase, a
function of oxygen partial pressure in the mitochondrion.1,2
The assessment of cytrochrome oxygenation state in complex
tissues in vivo is challenging because the near-infrared absorbance of hemoglobin overlaps with that of the cytochromes.
Furthermore, hemoglobin is present in most tissue regions
of interest at far higher concentrations than cytochrome C. It
is therefore not surprising that near-infrared spectroscopy of
cytochromes is subject to substantial errors due to difficulty
assigning the correct computational algorithm to account for
oxy- and reduced hemoglobin in tissue.3,4 In contrast, oxygen
use with insufficient oxygen delivery will lead to an increase
in reduced hemoglobin, and since hemoglobin chromophores dominate the near-infrared absorption spectrum, the
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METHODS
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space blood was removed from the catheters and discarded. Arterial and venous blood samples were analyzed
with a multiwavelength optical blood analyzer (OSM-3,
Radiometer Medical A/S, Copenhagen, Denmark) to determine oxygen saturation (Sao2 and Svo2).
The rate of blood draw from the jugular catheter was 1
mL over 30 seconds, to reduce reflux of nonjugular bulb
blood into the sample.18 The ratio of saturation in arterial
and venous blood claimed by each instruments manufacturer was used to calculate the reference saturation. For
INVOS, the weighting ratio was 25/75 arterial/venous and
for the others 30/70. The accuracy of the instruments could
then be calculated from this reference saturation and the
reading from the cerebral oximeter.
At the beginning of each study, 1 arterial and 1 venous
blood sample was drawn from each subject while they
breathed room air. Hypoxemia was then induced to 5 to 6
different targeted stable Sao2 levels (between 70% and 100%,
based on end-tidal gas analysis) by having subjects breathe
mixtures of nitrogen, air, and CO2 according to an established
protocol, previously detailed.17 Each Sao2 level was maintained at a steady state for at least 60 seconds, allowing oximeter readings to stabilize, at which point 2 simultaneous arterial
and 2 jugular bulb venous blood samples were obtained, 30
seconds apart during the steady state. The target saturation
values below room air, and nominal Pao2 corresponding to
each were as follows: 92%, 63 mmHg; 87%, 53 mmHg; 82%,
46 mmHg; 77%, 42 mmHg; and 70%, 37mmHg.
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RESULTS
Subject Demographics
Table 1.Demographics
Age (y)
Gender (male/female)
Weight (kg)
Body mass index (kg/m2)
Average hemoglobin (g/dL)
Skin
Light
Intermediate
Dark
Ethnicity
Caucasian
Asian
Hispanic
African American
Mixed/Multiethnic
28.2 4.6
14 (61%)/9 (39%)
72.2 12.0
23.4 2.3
12.8 1.4
12 (52%)
9 (39%)
2 (9%)
12
4
3
2
2
(52%)
(17%)
(13%)
(9%)
(9%)
Five hundred forty-two comparisons between pairs of arterial and venous blood samples and oximeter readings were
analyzed in the 23 subjects. For each paired blood draw, the
weighted value of arterial and venous saturation was used to
compute a bias by comparing this weighted saturation value
with the instrument reading. Table2 contains summaries of
this bias in terms of the mean bias, standard deviation of the
bias, SE, and root mean square (Arms) error values for specific
ranges of calculated weighted arterial and venous saturations.
The pooled Arms error, tallied from all 5 instruments, was 9.1%.
Over the entire range of oxygenation studied, the mean bias
SD (precision) and Arms errors were: FORE-SIGHT 1.76 3.92
and 4.28; INVOS 0.05 9.72 and 9.69; NIRO-200NX 1.13
9.64 and 9.68; EQUANOX 3-wavelength 2.48 8.12 and 8.47;
EQUANOX 4-wavelength 2.84 6.27 and 6.86.
Plots of cerebral oximeter bias versus the hemoximetermeasured weighted value for rSo2 are presented in Figure1.
3050
5070
7090
3090
134
2.74
3.18
3.55 to 9.03
12.58
4.19
37
2.33
3.81
10.02 to 5.37
15.39
4.42
179
1.76
3.92
5.95 to 9.48
15.43
4.28
3050
5070
7090
3090
16
3.20
8.78
20.40 to 14.01
34.42
9.08
136
1.25b
9.38
17.45 to 19.95
37.40
9.43
29
3.75b
10.66
27.77 to 20.27
48.04
11.13
181
0.05
9.72
19.32 to 19.42
38.74
9.69
3050
5070
7090
3090
10
1.08
9.17
16.90 to 19.06
35.96
8.77
129
0.62
9.01
17.34 to 18.59
35.93
9.00
40
7.33
9.35
26.28 to 11.62
37.91
11.79
179
1.13
9.64
20.30 to 18.04
38.33
9.68
3050
5070
7090
3090
7
7.74
3.55
0.7714.71
13.93
8.41
133
3.63
6.62
9.58 to 16.83
26.41
7.53
35
2.93
11.12
25.43 to 19.58
45.01
11.34
175
2.48
8.12
13.67 to 18.63
32.30
8.47
3050
5070
7090
3090
6
0.13
7.46
14.49 to 14.75
29.24
6.81
137
3.34b
6.31
9.20 to 15.88
25.08
7.12
33
1.25b
5.63
10.15 to 12.66
22.82
5.68
176
2.84
6.27
9.58 to 15.26
24.84
6.86
Bias was calculated as the difference between cerebral oximeter reading (Sco2) and the manufacturer-specified weighted arterial (Sao2) and jugular bulb (Svo2)
saturation.
Weighted Sao2/Svo2: weighting for jugular venous blood to arterial blood mixture is 75%/25% for the INVOS instrument and 70%/30 for the others.
Analysis of variance with repeated-measures and Tukey-Kramer honest significant difference used for multiple comparisons.
Arms = root mean square error; Sco2 = cerebral oximeter reading; Sao2 = arterial oxygen saturation; Svo2 = cerebral mixed venous hemoglobin saturation; interval =
upperlower limit of agreement.
a
All means in the row are different, P < 0.05.
b
Indicates pairs of means that are different statistically, P < 0.05.
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The FORE-SIGHT, NIRO-200NX, and EQUANOX 3-wavelength had significantly greater bias at lower Sao2, i.e., the
slope of the bias plots for these 3 instruments was negative
(Fig. 1, P < 0.0001 for significance of slope in all 3 cases).
The difference in mean bias between the high and low ends
of the saturation was relatively large (Table 2), meaning
that we have rejected hypothesis 1 for these instruments.
For example, for the FORE-SIGHT, there was a difference
in bias of about 10% saturation between weighted blood
saturations of 85% and 50%; for the NIRO-200NX, the bias
difference over this range was 15%; and for the EQUANOX
7600 3-wavelength instrument, the bias difference was 11%.
To determine whether increasing positive bias of the
cerebral oximeters with hypoxemia is related to the assumption of venous/arterial blood volume weighting, we plotted bias against the difference between arterial and cerebral
mixed venous saturations (i.e., nonweighted saturation) in
Figure2. In these plots, the slopes of bias in the EQUANOX
3-wavelength (0.12; CI, 0.020.22), FORE-SIGHT (0.06; CI,
0.02 to 0.14), and NIRO-200NX (0.14; CI, 0.27 to 0.013)
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Figure 3. Distribution of regression lines of bias values for individual subjects for a randomly chosen cerebral oximeter, the Nonin
EQUANOX 3-wavelength instrument. Each line, calculated by the
method of least squares, is the regression line of data from 1 of
the subjects. Sco2 = cerebral oximeter reading; Sa/vo2 = weighted
saturation of venous and arterial blood.
In Figure6, we plotted the A V saturation difference versus the arterial saturation for 6 representative subjects. The
slope of this relationship was significant, P < 0.0001.
DISCUSSION
Cerebral Oximeter Performance
Five cerebral oximeters all detected decreases in cerebral blood oxyhemoglobin saturation during systemic
hypoxemia in 23 healthy volunteer subjects. Based on the
manufacturer-defined ratio of cerebral venous and cerebral arterial blood detected by each device, we calculated
the bias between the cerebral oximeter reading and the
weighted values of arterial and cerebral mixed venous
Light
2.2 3.6a (93)
0.6 10.9 (94)
1.5 10.4 (92)
2.2 8.4 (92)
2.7 6.8 (92)
1.0 8.6 (463)
Medium
1.8 3.8 (70)
3.3 6.8 (71)
0.6 8.8 (71)
3.9 8.0 (67)
3.5 6.0 (68)
2.3 7.1 (347)
Dark
1.2 5.1a (16)
10.1 4.2 (16)
1.8 9.2 (16)
1.5 5.3 (16)
1.2 3.3 (16)
2.7 6.8 (80)
All
1.8 3.9 (179)
0.1 9.7 (181)
1.1 9.6 (179)
2.5 8.1 (175)
2.8 6.3 (176)
1.2 8.0 (890)
Skin
P value
0.049
0.14
0.91
0.56
0.80
0.24
Reference
Sa/vo2
P value
<0.0001
0.016
<0.0001
<0.0001
0.12
<0.0001
Skin
reference
P value
0.0004
0.15
0.011
0.53
0.18
0.21
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Female
2.0 4.5 (70)
7.4 9.0 (71)
4.9 11.4 (70)
1.7 8.5 (68)
0.35 6.9 (68)
Male
1.6 3.5 (109)
4.8 6.8 (110)
1.3 7.4 (109)
5.1 6.6 (107)
4.4 5.3 (108)
All
1.8 3.9 (179)
0.1 9.7 (181)
1.1 9.6 (179)
2.5 8.1 (175)
2.4 6.3 (176)
Gender
P value
0.61
0.0007
0.051
0.021
0.038
Reference Sa/vo2
P value
0.0002
0.02
<0.0001
<0001
0.25
Gender reference
P value
0.92
0.0003
<0.0001
0.0002
0.007
The multivariate analysis was by a repeated-measures model accounting for subject differences and compensated for repeated measures and difference values
of the reference Sao2/Svo2.
Sao2 = arterial oxygen saturation; Svo2 = cerebral mixed venous hemoglobin saturation.
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Study Limitations
Conclusions
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