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EMPIRICAL STUDIES doi: 10.1111/scs.

12303

Tympanic ear thermometer assessment of body temperature


among patients with cognitive disturbances. An acceptable
and ethically desirable alternative?

Lena Aadal RN, MScN, PhD(Head of Clinical Nursing Research)1, Lisbet Fog RN, MR(Nursing Specialist)2 and
Asger Roer Pedersen PhD(Statistican)1
1
Research Unit, Hammel Neurorehabilitation and Research Centre, Hammel, Denmark and 2H1, Hammel Neurorehabilitation and Research
Centre, Hammel, Denmark

Scand J Caring Sci; 2016 were used to analyse 284 simultaneous temperature
measurements.
Tympanic ear thermometer assessment of body
Ethics: Ethical approval for this study was granted by the
temperature among patients with cognitive
Danish Data Protection Agency, and the study was com-
disturbances. An acceptable and ethically desirable
pleted in accordance with the Helsinki Declaration 2008.
alternative?
Results: About 284 simultaneous rectal and ear tempera-
ture measurements on 27 patients were analysed. The
Aim: Investigation of a possible relation between body patient-wise variability of measured temperatures was
temperature measurements by the current generation of significantly higher for the ear measurements. Patient-
tympanic ear and rectal thermometers. wise linear regressions for the 25 patients with at least
Background: In Denmark, a national guideline recom- three pairs of simultaneous ear and rectal temperature
mends the rectal measurement. Subsequently, the rec- measurements showed large interpatient variability of
tal thermometers and tympanic ear devices are the the association.
most frequently used and first choice in Danish hospi- Conclusion: A linear relationship between the rectal body
tal wards. Cognitive changes constitute challenges with temperature assessment and the temperature assessment
cooperating in rectal temperature assessments. With employing the tympanic thermometer is weak. Both
regard to diagnosing, ethics, safety and the patients’ measuring methods reflect variance in temperature, but
dignity, the tympanic ear thermometer might comprise ear measurements showed larger variation.
a desirable alternative to rectal noninvasive measure-
ment of body temperature during in-hospital-based Keywords: brain injury, rehabilitation, measurement,
neurorehabilitation. body temperature, infrared tympanic thermometer.
Design: A prospective, descriptive cohort study. Consecu-
tive inclusion of 27 patients. Linear regression models Submitted 26 May 2015, Accepted 18 September 2015

It is difficult for patients with cognitive impairments to


Introduction
cooperate during the rectal measurement procedure
Measurement of body temperature is a frequent proce- because it penetrates their intimacy zone and they do
dure and accuracy of the readings is pivotal for diagnos- not understand the purpose of the procedure (4). Hence,
ing, treating and monitoring patients (1), because core they may experience lack of control causing anxiety (5,
temperature is essential information about health and 6), and there is a risk of patient pain and mucosa lesions
sickness (2). Rectal temperature has historically been (7, 8). Additionally, the increased stimulation and
considered a reference measure, but it is time-consuming unpleasant experiences may induce reactions such as
and difficult to obtain in certain patients (3). anxiety, violence and agitated behaviour (5). However,
the rectal measurement procedure is common among
patients with acquired brain injury because elevated tem-
Correspondence to:
peratures can be based on the response to exogenous
Lena Aadal, Head of Clinical Nursing Research, Hammel
stimuli requiring pharmacological interventions but also
Neurorehabilitation and Research Centre, Voldbyvej, 15 8450
post-traumatic hyperthermia, which may occur when
Hammel, Denmark.
E-mail: lena.aadal@hammel.rm.dk
hypothalamus is damaged (9).

© 2016 Nordic College of Caring Science 1


2 L. Aadal et al.

From this perspective, using a rectal thermometer noninvasive core measurement of body temperature
poses diagnostic, ethical and safety problems if the proce- among patients with acquired brain injuries.
dure entails the need to restrain patients with cognitive
changes. To resolve this dilemma, the availability of clini-
cally validated noninvasive body temperature measure- Tympanic ear devices
ment methods is essential. The tympanic thermometer detects the radiation of infra-
red energy by the tympanic membrane and converts this
Background energy factor into a temperature reading of the arterial
blood in the carotid artery.
The hypothalamus plays a key role in the thermoregula-
Measuring the body temperature with an infrared tym-
tory function in humans and integrates thermal signals
panic thermometer has been debated because it has a rela-
received from sensors throughout the central nervous
tively low reproducibility compared with the rectal
system involving the spinal cord, midbrain, reticular for-
measurement (1, 9, 13, 15, 18). A number of studies have
mation and nervous vagus. Studies have shown that nor-
compared the various modes of thermometry (7, 11, 12,
mal temperature ranges between 36.2 and 37.5 °C (8)
17, 19–21). Taking the history of rectal temperature mea-
and undergoes a regular circadian fluctuation of 0.5–
surement as a reference measure into consideration, there
1.0 °C, where it is lowest late at night or early morning
are remarkably few studies of the accuracy and repeatabil-
and highest in the evening. Additionally, the normal
ity of infrared tympanic measurements with rectal ther-
body temperature shows interindividual variation (10)
mometry as reference in detecting and excluding fever (3,
that depends on weight, gender and age (2).
10, 16, 19, 22, 23). The studies of these early versions of
The measured body temperature depends on the type
the infrared tympanic thermometers emphasised risk of
of thermometer and the body site used for the measure-
misdiagnosis and questioned the accuracy of the measure-
ment (11). Shell and core temperature recordings are
ment, but the results were conflicting. None of the tested
used to measure body temperature in clinical practice.
thermometers were found to be appropriate alternatives to
The core temperature measurement requires invasive
the rectal thermometer (1, 16).
techniques in the oesophagus, bladder or pulmonary
In a recent study, Haugan et al. (16) found that the
artery (7, 12). Of these, the pulmonary artery catheter
infrared tympanic thermometer measured the temperature
measurement is considered the gold standard (8). How-
lower than rectal temperature and an indication of higher
ever, these measurement methods require advanced
variation in temperature measurements made in the ear.
measuring equipment which is unsuitable in clinical
However, this study used older versions of the tympanic
rehabilitation practice. Traditionally, the noninvasive rec-
thermometer released on the market in 2006 and 2007. In
tal site has been assumed to estimate the core tempera-
2012, a new and improved version, GeniusTM 2, was
ture (13, 14). Following this, axillary and oral readings
released by Covidien. In the sequential generations of
are adjusted to the rectal by adding 0.3 and 0.5 °C,
thermometers, improvements of geometry and algorithms
respectively. These adjustments are estimated on clinical
have been developed to ensure that the displayed result
experience, but the evidence for such relationships is not
reflects the tympanic temperature. Hence, the newest ver-
present (15). To the best of our knowledge, a more gen-
sion might meet the clinicians’ requested improvements of
eral linear relationship, indicating that a measured ear
repeatability in noninvasive temperature assessments.
temperature added a constant can estimate a temperature
In summary, cognitive disturbances are frequent
recorded in another site, has not been considered in the
among patients with acquired brain injury. Cognitive
literature.
changes constitute the challenges of cooperating in rectal
In Denmark, a national guideline recommends rectal
temperature assessments. With regard to diagnosing,
measurement. Consequently, rectal thermometers and
ethics and the patients’ safety, the tympanic ear ther-
tympanic ear devices are the most frequently used and
mometer might be a desirable alternative to rectal mea-
first choice in Danish hospital wards (3). Unlike this prac-
surement during in-hospital-based neurorehabilitation.
tice is noninvasive oral, axillary and tympanic ear mea-
The focus of this research study is to investigate a pos-
surement devices used in Norway for predicting core
sible relation between body temperature measurements
temperature. Here, the infrared tympanic thermometers
using the current generation of tympanic ear thermome-
are the most commonly used devices in clinical practice
ter and rectal temperature measurements.
(16). In relation to patients with cognitive disturbances,
the tympanic thermometer has been found acceptable in
Methods
predicting rectal temperatures in a population of elderly
who often demonstrate functional disturbances similar to The prospective, descriptive cohort study was carried out
patients with acquired brain injuries (3, 17). Hence, the in one of the wards at a neurorehabilitation hospital.
ear may provide an acceptable and ethically desirable Data were collected during 3 months.

© 2016 Nordic College of Caring Science


Tympanic ear thermometer assessments 3

supplemented by surrogate informed consent from the


Participants
closest relative. Relatives were not allowed to give con-
Consecutive inclusion at admission to the ward used the sent for the patient, but their familiarity with the project
following criteria: was needed, in order to involve them in the interpreta-
tion of the patient’s expressions indicating violation in
relation to the intimate zones. Participation was
• Age ≥ 18 years.
voluntary, anonymity was preserved, and withdrawal
• Severe acquired brain injury despite aetiology.
was possible at any time without consequences for their
• Prescribed noninvasive assessments of body
care; no patient was excluded from the study. Ethical
temperature.
approval for this study was granted by the Danish Data
• Understanding Danish.
Protection Agency, and the study was completed in
• Informed consent from patient and closest relative.
accordance with the Helsinki Declaration (2008).
Exclusion criteria:
Permission to conduct the study was obtained from the
• Patient isolation.
rehabilitation hospital.
• Recent infection in the ear.
• Patients who refused rectal measurements verbally or
nonverbally, for instance by efforts to protect his or Material
her intimate zones by hands or garment.
Recorded data. All thermometers were labelled with the
patient’s name and used for all individual measurements.
Measurement As recommended by Coviden, the initial ear temperature
was measured in both ears and all later measurements
All data were measured by nurses, certificated health care
were conducted in the ear indicating the highest temper-
workers or nursing students who had accomplished a
ature. Temperatures were measured simultaneously using
training programme conducted by the investigators. The
tymphanic and rectal thermometers. Additional, data reg-
purpose of the programme was correct use and cleaning
istered were the patient’s age, sex, pulse rate and time of
of lenses at the tympanic infrared thermometers. Further-
assessment (2, 10, 22).
more, the staff learned how to fill out the data registra-
tion form. Subsequently, the investigators were available
Statistical analysis. Simultaneous ear and rectal tempera-
as supervisors. Tymphanic measurements were conducted
ture measurements were used to estimate a population
using GeniusTM 2 by Covidien, which meets the CEN and
level linear model for the prediction of rectal tempera-
ASTM technical standards in 0.1 °C (36.7–38.9). The
ture from measured ear temperature (linear mixed
GeniusTM 2 Peak Select System records and analyses up to
model with random subject specific coefficients; PROC
100 separate measurements and selects the most accurate
MIXED (SAS Institute Inc., Cary, NC, USA). Intraindi-
temperature in less than 2-seconds. Tympanic infrared
vidual standard deviations of both types of temperature
thermometry accesses the radiation of infrared energy by
measurements were compared using the Wilcoxon
the tympanic membrane to determine the body‘s temper-
signed rank test. For patients with at least three simul-
ature. In rectal measurements, Kivex Clinic blue rectal
taneous ear and rectal temperature measurements, indi-
thermometer was used. It has an accuracy of 0.1 °C. All
vidual linear models were estimated, and the estimated
temperatures were entered manually on the data registra-
slopes were compared between genders using the Wil-
tion sheet. Only a few minutes between infrared ther-
coxon rank sum test and tested for association with age
mometry and rectal recording was accepted. All
using Spearman’s rho.
thermometers were labelled and used for only one speci-
fic patient during the rehabilitation course. Temperature
measurements were conducted in accordance with the Results
medical prescription and the local clinical guideline, in In total, 290 rectal and 316 ear temperature measure-
order to collect data as similar to daily practice as ments were recorded for 27 patients. No simultaneous
possible. ear temperature measurement was obtained for 6 of the
290 rectal measurements. Hence, 284 simultaneous rectal
Ethics and ear temperature measurements from 27 patients
(nine women, 18 men, age range: 33–77 years, median
Rectal temperature measurements are prescribed as an
age: 62 years) were analysed (1–43 measurements pr.
ordinary intervention, and this study adds tympanic mea-
patient, median 8).
surement with a minor risk to violate the patient’s inti-
macy zone. Due to the patients’ vulnerability, informed The population model for converting measured ear tem-
verbal consent was obtained from the patient perature into a predicted rectal temperature was (Fig. 1)

© 2016 Nordic College of Caring Science


4 L. Aadal et al.

Figure 1 The 284 simultaneous rectal and ear temperature Figure 2 Patient-wise standard deviations of measured temperatures
measurements (dots) and the estimated population model for for the 25 patients with at least three pairs of simultaneous ear and
converting measured ear temperature into a predicted rectal rectal temperature measurements.
temperature (solid line). The grey area indicates the 95%-prediction
uncertainty associated with the prediction, and the dotted line is the
identity line (agreement between ear and rectal temperature). pffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi
37:3  1:96  0:0863 ¼ 37:3  0:58 ¼ ½36:7; 37:9

Predicted rectal temperature ¼ 37:3 The interpretation is that at measured ear temperature
of 37 °C, where the predicted rectal temperature equals
þ0:35  ðMeasured ear temperature  37Þ
37.3 °C, the 95% prediction interval [36.7; 37.9] contains
with 95%-prediction uncertainty limits given by
95% of all measured rectal temperatures. This prediction
uncertainty increases as the measured ear temperature
1:96
pffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi increases/decreases from 37 °C (Fig. 1).
 0:0863 þ 0:0233  ðMeasured ear temperature  37Þ Patient-wise standard deviations of measured tempera-
tures could be calculated for 25 patients, which had at
Hence, with measured ear temperature 37 °C, the least three pairs of simultaneous ear and rectal tempera-
predicted rectal temperature is 37.3 °C, and for each ture measurements. For the remaining two patients, only
increment/decrement in measured ear temperature of a single pair of temperature measurements was available.
1 °C above/below 37 °C, the predicted rectal tempera- The patient-wise variability of measured temperatures
ture increases/decreases by 0.35 °C. In particular, the was significantly higher for the ear measurements
difference between predicted rectal and measured ear (p = 0.0025, Fig. 2).
temperature depends on the measured ear temperature. Patient-wise linear regressions for the 25 patients with
At approximately 37.5 °C measured ear temperature, at least three pairs of simultaneous ear and rectal temper-
the predicted rectal temperature is the same. Con- ature measurements showed large interpatient variability
versely, the predicted rectal temperature is larger/smaller of the association (Table 1).
than the measured ear temperature for measured ear The association was found to be statistically significant
temperatures above/below 37.5 °C. This is due to the (slope coefficient different from zero) in only 6 of the 25
nonunity slope coefficient of 0.35 in the prediction cases, which in part can be explained by the small num-
equation (Fig. 1). Although the estimated slope coeffi- ber of measurements for many patients, although non-
cient is subject to estimation uncertainty (95%-confi- significant associations were also found for several
dence interval [0.25; 0.45]), it is, however, significantly patients with 10 or more measurements (6 of 9 patients,
different from unity (p < 0.0001) at the usual statistical 67%). The estimated slope coefficient varied considerably
significance level of 5%. Hence, the best fitting predic- between patients (range: [1.00; 0.91], median: 0.16),
tion line is not parallel to the identity line (dashed line indicating quite different temperature associations
in Fig. 1) in this patient population providing evidence between them, and was not associated with age (Spear-
that measured ear temperature cannot be converted into man’s q = 0.17, p = 0.4045) or gender (p = 0.6368).
a measured rectal temperature by adding a fixed tem- The 95% prediction uncertainties ranged 0.09–1.07 (me-
perature value. dian: 0.44), and the coefficient of determination, R2, ran-
The 95% prediction uncertainty also depends on the ged 0.002-0.70 (median: 0.15), which indicates weak
measured ear temperature. It is smallest at measured ear relationship between the two temperatures in many
temperature 37 °C, where the 95% prediction uncer- patients. By inspection of the individual linear regressions,
tainty limits are: different types of associations could be identified (Fig. 3).

© 2016 Nordic College of Caring Science


Tympanic ear thermometer assessments 5

Table 1 Patient characteristics (gender, age) and individual estimated linear models for converting measured ear temperature into a predicted
rectal temperature for the 25 patients with at least three pairs of simultaneous ear and rectal temperature measurements (n). The rows are sorted
in descending order of the number of measurements. The estimated linear models are presented by the predicted rectal temperature (At 37° C)
at measured ear temperature 37° C, the slope (Slope) of the linear model with 95%-confidence interval and p-value for the null hypothesis of
zero slope, and strength of the linear relationship quantified by the 95%-prediction uncertainty (95%-PU) and the coefficient of determination
(R2). The coefficient of determination can be interpreted as the fraction of the variability in the measured rectal temperatures that can be
explained by variability in the measured ear temperatures through the linear model.

Patient ID Gender Age n At 37 °C Slope 95%-PU R2

15 Female 39 43 37.3 [37.1; 37.5] 0.20 [0.01; 0.42], p = 0.0654 0.86 0.08
12 Male 63 34 37.3 [37.2; 37.4] 0.52 [0.28; 0.75], p = 0.0001 0.48 0.39
3 Female 63 25 37.4 [37.2; 37.6] 0.10 [0.51; 0.31], p = 0.6279 0.55 0.01
32 Male 63 19 37.2 [37.1; 37.2] 0.07 [0.08; 0.21], p = 0.3285 0.22 0.06
18 Male 58 16 37.4 [37.2; 37.6] 0.69 [0.36; 1.02], p = 0.0005 0.35 0.59
36 Male 57 15 37.4 [37.2; 37.5] 0.63 [0.38; 0.88], p = 0.0001 0.45 0.70
28 Female 61 13 37.3 [37.1; 37.5] 0.19 [0.27; 0.65], p = 0.3787 0.46 0.07
24 Male 63 11 37.3 [37.1; 37.6] 0.16 [0.39; 0.72], p = 0.5225 0.40 0.05
35 Male 68 10 37.0 [36.7; 37.3] 0.19 [1.03; 0.65], p = 0.6152 0.46 0.03
22 Female 56 9 37.0 [36.9; 37.2] 0.80 [0.32; 1.27], p = 0.0055 0.25 0.69
31 Male 66 9 37.0 [36.6; 37.4] 0.48 [0.06; 0.90], p = 0.0302 0.33 0.51
1 Male 33 8 37.4 [37.0; 37.7] 0.27 [0.46; 1.00], p = 0.3966 0.55 0.12
9 Male 69 8 37.1 [36.8; 37.4] 0.09 [0.34; 0.52], p = 0.6116 0.44 0.05
21 Male 49 8 36.7 [36.3; 37.2] 0.79 [0.15; 1.42], p = 0.0234 0.47 0.60
11 Male 77 7 37.2 [36.6; 37.8] 0.68 [0.37; 1.72], p = 0.1565 0.93 0.36
17 Male 65 7 36.8 [36.7; 36.9] 0.05 [0.05; 0.16], p = 0.2533 0.09 0.25
2 Female 68 6 37.4 [36.8; 37.9] 0.64 [0.84; 2.13], p = 0.2943 0.95 0.27
7 Female 39 5 37.7 [37.2; 38.2] 0.91 [0.24; 2.06], p = 0.0857 0.66 0.68
10 Female 61 5 37.1 [36.3; 37.9] 0.21 [1.78; 1.35], p = 0.6925 0.36 0.06

For some patients (Fig. 3a,b), the difference between unreliable for a neuroscience ICU (24). Data are collected
the two temperatures appeared constant (independent of in clinical practice and may be influenced by incorrect
the measured ear temperature), although with different use, incorrect registration or the soiled lenses of the ther-
signs (Fig. 3a: rectal > ear; Fig. 3b: rectal < ear), whereas mometers. These critical factors need to be addressed in
for others (Fig. 3c,d), the measured rectal temperature educating staff and critique of studies using specific
remained fairly constant, while the measured ear temper- assessment devices.
ature varied 1.5–2 °C. For some (Fig. 3e,f), the individual Although the rectal measurement is considered the
temperature relationship resembled the one found on the reference standard in this study, we acknowledge that it
population level (Fig. 1). Hence, for many patients, the may be imperfect in many ways in our context. Inva-
population-based prediction model (Fig. 1) will be biased. sive temperature measurement is neither suitable for
routine clinical practice, nor easily applicable in patients
with cognitive disturbances. Measurements from differ-
Discussion
ent areas of the body may provide different results and
The performance of the tympanic measurements in this should not be directly compared, even if taken at the
study may reflect a number of factors. Our results must same time (22). This study showed a weak linear rela-
be treated with caution because of the small number of tionship between body temperature by rectal assessment
patients, none of whom were highly febrile. The mea- and temperature assessment applying the tympanic ther-
surement of body temperature was conducted by tym- mometer both on individual and group level. This is
panic ear and rectal thermometers. Both of these consistent with other studies which found no evidence
methods are associated with uncertain accuracy influ- for adjusting one site to another (15) and large varia-
enced by factors such as lack of training or poor equip- tions between sites due to intraindividual variation.
ment handling, and correct and observer-independent (15). It is claimed that ear temperature is on average
use of infrared thermometry can be challenging in a clin- 0.2–1.3 degrees below rectal temperature (25). However,
ical setting (22), which may explain the observed higher we found high interpersonal variation in the correlation
variability in ear temperature measurements. Many vari- between sites. In one case (Fig. 2a), the rectal measure-
ables involved in the use of tympanic thermometers com- ments were higher than the tympanic, while these were
bine to produce measurements that may be too lower in another case (Fig. 2b). A review showed that

© 2016 Nordic College of Caring Science


6 L. Aadal et al.

(a) (b)

(c) (d)

(e) (f)

Figure 3 Different types of associations identified between measured ear and rectal temperatures. (a & b): Similar difference between the two
temperatures at all measured ear temperatures although with different signs (A: rectal>ear, B: rectal<ear). (c & d): Almost constant rectal
temperatures associated with ear temperatures varying 1.5-2° C. (e & f): Individual temperature relationships similar to that found on the
population level (Fig. 1).

infrared tympanic thermometry had low sensitivity, but neurorehabilitation setting is challenged. Despite mea-
high specificity in detecting and excluding fever compared surement site prescriptions or care, it may be recom-
with rectal measurements (22). Hence, simultaneous mended not to base decisions on a single vital sign, but a
baseline measurements are required in clinical practice, in holistic picture of the patient’s clinical condition.
order to identify temperature incensement of diagnostic Viewed independently, both measuring methods reflect
relevance when different sites are needed. Taking the variance in temperature, but ear measurements showed
diversity of our findings into consideration, the need for larger variation. Large variations are found between sites
accurate and continuous temperature screenings in a due to intraindividual variation (15). The variation can

© 2016 Nordic College of Caring Science


Tympanic ear thermometer assessments 7

partly be explained by the tympanic measurements instan- patients with cognitive disturbances, but the assessments
taneously responding to changes in the set point tempera- need to be supplemented by other vital data in detecting
ture (15), which is considered to reflect the core and excluding temperature variation. Given the wide-
temperature (7). Due to the fact that tympanic membrane spread use of infrared tympanic thermometer, further
and the hypothalamus share blood supply, the tympanic documentation of diagnostic accuracy and repeatability of
measurements reflect the temperature of the arterial blood newer models used in a clinical setting is needed.
affecting the thermoregulatory centres (8). The rectal tem-
perature is more stable because of its position far from the
Author contributions
hypothalamus in a sealed area with low emission of heat.
It lags behind changes at other sites especially during rapid Aadal contributed to study conception/design; data analy-
temperature changes for at least 20 minutes (2). sis; drafting of manuscript; critical revisions for important
intellectual content; and supervision. Fog contributed to
study conception/design, data collection and critical revi-
Conclusion
sion of manuscript. Roer Pedersen contributed to study
A linear relationship between the rectal body tempera- conception/design; data analysis; statistical expertise; and
ture assessment and the temperature assessment employ- critical revisions for important intellectual content.
ing the tympanic thermometer is weak. Hence, there is a
substantial uncertainty in estimating and predicting tem-
Funding
peratures between the two sites in a population, but also
among individuals. Both instruments reflect the core Sources of grants, equipment or drugs was not received.
temperature, but the variation in ear measurements was
higher.
Ethical approval
Ethical approval for this study was granted by the Danish
Relevance to clinical practice
Data Protection Agency, and the study was completed in
The tympanic thermometer appears to be an immediate accordance with the Helsinki Declaration 2008.
alternative to the rectal thermometer method among

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