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  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Visual Control System Based on Nociception-Analgesia Index for Patients in a Vegetative State/Unresponsive Wakefulness Syndrome and Minimally Conscious State *</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <string-name>Svetlana Degtiareva</string-name>
          <email>svetlanadegtiareva@itmo.ru</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Ivan Polukhin</string-name>
          <email>ivanpolukhin@yandex.ru</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Irina Smirnova</string-name>
          <email>igsmirnova@itmo.ru</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Ekaterina Kondratieva</string-name>
          <xref ref-type="aff" rid="aff1">1</xref>
        </contrib>
        <contrib contrib-type="author">
          <string-name>Vladislav Bougrov</string-name>
          <email>vladislav.bougrov@niuitmo.ru</email>
          <xref ref-type="aff" rid="aff0">0</xref>
        </contrib>
        <aff id="aff0">
          <label>0</label>
          <institution>ITMO University</institution>
          ,
          <addr-line>Saint-Petersburg</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>Polenov Neurosurgical Institute, the Branch of Almazov National Medical Research Centre</institution>
          ,
          <addr-line>Saint-Petersburg</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
      </contrib-group>
      <pub-date>
        <year>2020</year>
      </pub-date>
      <fpage>19</fpage>
      <lpage>29</lpage>
      <abstract>
        <p>Considering people who are in a coma, doctors have to rely on physical clues and information provided by monitoring systems. It is commonly used for patients in a vegetative state, as contact with them is difficult. Taking into account the typical workload of the doctor, they require several tools to monitor the coma depth, since it is hard to perform a clinical evaluation hourly. Therefore, visual perception and monitoring of physical state for coma personnel proved to be more convenient for prompt decision-making. In a number of cases, it would be possible to make prognosis for their recovery and monitor effectiveness of treatment courses. Visual control system based on RGB led strips according to the ANI range of values was created. In conclusion, the connecting scheme of ANI monitor with implementation of visual object was presented.</p>
      </abstract>
      <kwd-group>
        <kwd>ANI-monitoring</kwd>
        <kwd>Coma</kwd>
        <kwd>Index of Analgesia/Nociception</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>-</title>
      <p>
        Caring for health is somehow linked with the automatic systems [
        <xref ref-type="bibr" rid="ref1">1</xref>
        ]. Special attention
is paid to healthcare industry because monitoring and controlling physical signs like
temperature, pressure, humidity, lights are more effective instead of being in stuck into
bedside monitor. It should be mentioned monitoring of coma patients is tough job for
staff to control each patient’s 24 hours, that may lead to difficulties due to human error.
Thus, automatic products are the main interest for more convenient and comprehensive
medical monitoring.
      </p>
      <p>The main idea is to develop a non-intrusive visual control system without
compromising the patients’ privacy which can display any patient data in any part of body and
issue a timely warning by visible light.
2</p>
    </sec>
    <sec id="sec-2">
      <title>Relevance</title>
      <p>
        Diagnostic methods for assessment of impairment of conscious level are still widely
used in the treatment in an Intensive Сare Unit. It includes tests of orientation, attention,
memory, language and visual-spatial skills. At first, J. Bennett invented Glasgow Coma
Scale (GCS) for reliable and objective way of recording the conscious state of a person
in 1974. The Mini-Mental State Exam (MMSE) by Folstein M.F. was developed in
1975 as test of cognitive function among the elderly [
        <xref ref-type="bibr" rid="ref2">2</xref>
        ]. Nevertheless, traditional
neuropsychological tests are not enough as a daily routine screening tool and require
continuous supervision by a paramedical assistant. Besides physiological assessment is a
critical step for the detection of signs of consciousness.
      </p>
      <p>
        Recent applied developments opened up new avenues for research and exploration
in the all fields including medical and health care industry. They are able to make a
better description of what consciousness actually is. Samuli Siltanen from University
of Helsinki proposed electrode helmet, using electrical impedance tomography,
however, it was found information is not easily extracted from the results since electricity
flows throughout the body whereas x-rays travel only in straight lines [
        <xref ref-type="bibr" rid="ref3">3</xref>
        ]. The main
drawback is application after surgery, before removing stitches and in the presence of
head wounds is possible. Akane Oyama, Shuko Takeda proposed completely different
method, the eye tracking-based cognitive scores for sensitive detection of cognitive
impairment [
        <xref ref-type="bibr" rid="ref4">4</xref>
        ]. The ubiquity of haptic technology created new care model advanced
medical tools simultaneously. As an example, Far Eastern Federal University VR/AR
Center conducts research on the use of VR / AR technologies in rehabilitation program
for stroke patients with impaired motor functions.
      </p>
      <p>
        In Intensive Care Unit special attention is paid to bedside monitors for prompt
evaluation after surgery under general anesthesia. They are Analgesia Nociception Index
Monitoring, Bispectral index Monitoring, MedStorm. [
        <xref ref-type="bibr" rid="ref5">5</xref>
        ]. Even through presented
methods are extremely important for coma patients, there has been no complex method
for reading physical signs of coma patient and simultaneous displaying on textile visual
control system so far. We present approach of reading Analgesia Nociception Index
from monitor and further visual interpretation on a visual object. ANI Technology was
chosen as available technology in Almazov Research Medical Centre participating as
partner. Jacket was offered as the initial visual object.
3
      </p>
    </sec>
    <sec id="sec-3">
      <title>Medical preconditions</title>
      <p>
        The main idea of the proposed method is that the binary image is transformed into a
geometric graph where each node corresponds to the pen position at some point during
writing and edges model the pen movement between nodes. This way, the initial A
coma is a deep state of prolonged unconsciousness as a result of traumatic brain injury,
Visual Control System Based on Nociception-Analgesia Index for Patients in a Vegetative… 3
stroke, brain tumor, diabetes or an infection [
        <xref ref-type="bibr" rid="ref6">6</xref>
        ]. But coma usually lasts for less than 2
to 4 weeks in itself, then a person may wake up into a vegetative state/unresponsive
wakefulness state (VS/UWS) or minimally conscious state (MCS). Patients in VS/UWS
and MCS either do not perceive reality at all or perceive it partly. It requires operative
action to preserve life and brain function as well as visual controlling of basic physical
cues such as heart rate, pulse, body temperature.
      </p>
      <p>The continuous visual-based monitoring of the VS/UWS and MCS coma patients
could be more convenient and comprehensive, cause the usual monitoring process can
lead to a tough load for health-care professionals Imaging techniques, including
functional magnetic resonance imaging, FDG positron emission tomography is proven to
be useful in determining the diagnosis of VS/UWS and MSC. However, diagnosis of
the VS/UWS and MSC should be based on a patient’s clinical history and on simple
visual observations as well. In this context the development of visual control system
with established light-emitting diodes allows to facilitate control process, which is
commonly used in Intensive Care Unit, Critical Care Unit, and Emergency Rooms of
hospital. Thus, in the emergency cases, the doctor is able to monitor patient condition
efficiently to reduce time consumption.
4</p>
      <p>Analgesia-nociception index for predicting of hemodynamic
reaction
Currently, it is possible to make pain assessment by determining the nociception and
analgesia index using an ANI monitor. This technology has been proposed for
longterm monitoring of nociception. ANI monitoring is a non-invasive technique that can
be used in patients of all age groups to avoid effects of over or under-dosing of
analgesics during surgeries. ANI technology also monitors the parasympathetic tone, which
provides information about the patient’s comfort, i.e. the appearance of pain or stress.</p>
      <p>The ANI index is expressed on a scale between 0 and 100 %. It expresses the relative
amount of p tone present as compared to sum of sympathetic and p activities. When
level of anesthesia is more than pain, it is between 50 and 70, patient has a dominant
parasympathetic tone and possibly less pain/nociception. When the ANI index is lower
than 50, hemodynamic reactivity is very likely. Thus, clinicians make a decision which
analgesics are preferable.</p>
      <p>Figure 1 shows elements of the ANI monitor.
They are a single sensor and a dual sensor. The sensor itself is divided into two areas:
adhesive area and the other active region which is covered with a conductive gel. A
dual sensor is applied on the patient's chest. Electrodes are connected to the acquisition
device using the cable. The last one is connected to the ANI monitor.
5
5.1</p>
    </sec>
    <sec id="sec-4">
      <title>Methods</title>
      <p>Visualization method
Jacket-based visual system with established light-emitting diodes is a current offer and
serves as primary prototype. It consists of 6 strips of 29 light-emitting diodes with pixel
addressing. The matrix 6x29 is presented in Figure 2.
Each element is setting the color code in the HEX format (0; 0; 0) for addressing
specific light elements.
The principle of data interpretation in accordance with the range of values from 0 to
100 % is presented. During treatment, the patient monitor is continuously monitoring
the coma patient to transmit the important information. It based on the ANI index and
the lighting effects on a jacket. ANI range from 0 to 100% was divided into 3 ranges or
lighting effects for the jacket: lower than 50%, 50-69%, 70-100%. Jacket is light up
depending on which range the ANI index falls. The latest simplifies the observation of
physiological sign and increases the monitoring effectiveness. Moreover, using the ANI
index interpretation method during anesthesia it is possible to predict the risk of a
hemodynamic reaction in response to nociceptive stimulation.</p>
      <p>Visual Control System Based on Nociception-Analgesia Index for Patients in a Vegetative… 5</p>
      <p>
        Monitoring system for patients in a coma by pain assessment
A diversity of pain for patients with prolonged disorders of consciousness (PDOC)
VS/UWS and MSC is defined by the International Assoсiation for the Study of Pain
(IASP) as unpleasant sensory and emotional experience related to real or potential
tissue damage…». It raises the question of whether sensory or emotional experience is
possible for such illnesses. It is obvious that the conscious perception of pain in this
category of patients is non-existent. Simultaneously, some processes which are afferent
signals of pain are constantly presented in a patient with congestive heart failure. They
are spasticity, contractures, calcifications and polyneuromyopathy [
        <xref ref-type="bibr" rid="ref2 ref3">2-3</xref>
        ].
      </p>
      <p>One more issue is the influence of nociceptive afferentation without pain experience
on the possibility of consciousness recovery. Traditionally, pain therapy is aimed at
stopping pain experience. Assuming that patients with heart failure feel no pain, the
stabilization of autonomic parameters may be insufficient. The main task to solve this
issue is studying the functional features of the central nervous system. The group of
patients highlighted in recent years with the phenomenon of “covert consciousness” is
of particular interest. During the studies of the response to pain stimulus (PS), the
informative significance of the scale for assessing pain in patients in a coma and device
for the study of cardiac interval using the ANI monitor were studied
(analgesia-nociception index). ANI monitor was used for 29 patients with congestive heart failure (9
patients in a VS/UWS and 20 patients in MCS). The age of the patients ranged from 22
to 56 years (the average age is 34.75 ±11.54). Measurements are presented in the
Figure 4.</p>
      <p>The average value of the ANI index for patients in a VS/UWS is - 67.44 ± 10.73
before PS, 49.55 ± 14.49 during PS, and 73.66 ± 10.48 30 minutes after. The average
values of the ANI index in patients in MCS: 66.25 ± 14.11 before, 45 ± 16.12 during
PS and 66.55 ± 18.1 after. A comparison of the average values of the ANI index
between two groups of patients before, during PS and 30 minutes after PS did not reveal
statistically significant differences (p&gt; 0.05).</p>
      <p>Thus, the same dynamics of changes in the ANI index was noted both in the initial
and in response to PS. The initial value of ANI index was higher than 66.25, indicating
the absence of pronounced vegetative reactions in the dormancy paradigm.
80
60
40
20
0</p>
      <p>The average value of the ANI index
67,44
66,25
73,66</p>
      <p>66,55
49,55</p>
      <p>45
VS/UWS
(before PS)</p>
      <p>MCS (before</p>
      <p>PS)</p>
      <p>VS/UWS
(during PS)</p>
      <p>MCS (during VS/UWS MCS</p>
      <p>PS) (30 minutes (30 minutes</p>
      <p>after) after)</p>
    </sec>
    <sec id="sec-5">
      <title>Designing of visual control system</title>
      <p>Further, it describes a framework with simplex communication.</p>
      <p>The jacket consists of three layers: fabric, diffusing and the main with established
light-emitting diodes strips. Currently, it is operating from a 220 VAC and has 3
lighting effects. The jacket scheme is shown in Figure 5.
The electrocardiogram signal from the electrode on the chest is processing by the
acquisition sensor. The digitized ECG signal is transmitted to the ANI monitor using the
RS232 protocol. The jacket is connected to the monitor using a specially designed
Visual Control System Based on Nociception-Analgesia Index for Patients in a Vegetative… 7
cable. It lights up depending on the ANI index (nociception and anesthesia index) and
range it falls.</p>
    </sec>
    <sec id="sec-6">
      <title>Results</title>
      <p>The visual control system, integrated in the ANI-monitoring scheme, was developed.
The jacket-based visual control system was tested in the Intensive Care Unit in Polenov
Neurosurgical Institute. The average values of ANI index for patients in a VS/UWS
and MCS were measured. It was found previously that the ANI index is 10 minutes
ahead of the change in hemodynamic response parameters within nociceptive
stimulation during general anesthesia. So, in conclusion, the visual control system allows to
make the process of informing about timely medical intervention faster. However
clinical judgment should always be used when interpreting the ANI index in conjunction
with other available clinical signs.</p>
    </sec>
  </body>
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