<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252301</url>
  </required_header>
  <id_info>
    <org_study_id>0054-17-MMC</org_study_id>
    <nct_id>NCT03252301</nct_id>
  </id_info>
  <brief_title>Assessment of Pain in Surgical Patient by PMD 200</brief_title>
  <official_title>Assessment of Pain in Surgical Patient by PMD 200</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Hospital, Kfar Saba, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Hospital, Kfar Saba, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial will estimate post-operative pain management in elective surgical patients using&#xD;
      the PMD-200 device. The device measures physiological parameters by placing a non-invasive&#xD;
      sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level&#xD;
      will be estimated before surgery (baseline), after surgery and during administration of&#xD;
      parenteral analgesia. Treatment and analgesia will be given according to clinical&#xD;
      considerations and standard ward protocols. The device measurements won't influence the&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background The key to adequate pain management is assessing its presence, duration and&#xD;
           severity, identifying those who require intervention, and evaluating the treatment&#xD;
           efficacy. Pain relates to both the noxious input, via peripheral nerves, and to central&#xD;
           modulation, thereby, integrating different modalities such as affect, experience or&#xD;
           personality. Nociception refers to the peripheral and central nervous system (CNS)&#xD;
           processing of information about the internal or external environment, as generated by&#xD;
           activation of nociceptors. Typically, noxious stimuli, including tissue injury, activate&#xD;
           nociceptors that are present in peripheral structures and that transmit information to&#xD;
           the spinal cord dorsal horn (or its trigeminal homologue - the nucleus caudalis). From&#xD;
           there, the information continues to the brainstem and ultimately the cerebral cortex,&#xD;
           where the perception of pain is generated. The pain is a product of higher brain center&#xD;
           processing, whereas nociception can occur in the absence of pain.&#xD;
&#xD;
           Objective assessment of nociception poses a multitude of challenges. First, sedated or&#xD;
           unconscious patients by definition cannot experience pain. Under these circumstances, it&#xD;
           is more accurate to assess the nociception level. A body of research suggests that not&#xD;
           managing nociception can lead to central changes in pain pathways that predispose&#xD;
           individuals to chronic pain states.&#xD;
&#xD;
           Current &quot;gold-standard&quot; pain assessment tools rely on self-reporting, requiring an&#xD;
           individual both to process external information and to communicate this personal&#xD;
           experience.&#xD;
&#xD;
           Circumstances exist where self-reporting is not possible, or where it is unreliable. In&#xD;
           these situations, surrogate markers utilize changes in behavioral or physiological&#xD;
           parameters. However, their use can be associated with considerable shortcomings. They&#xD;
           may be unreliable, hampered by observational bias, or influenced by disease processes or&#xD;
           pharmacological interventions. Developing an objective method of pain assessment&#xD;
           therefore needs to ensure tools that are sensitive and specific to pain. They need to be&#xD;
           observer-independent, not reliant on the patient's ability to communicate and not&#xD;
           influenced by disease characteristics.&#xD;
&#xD;
           A novel measure of nociception is the nociception level (NoL) index. It is based on&#xD;
           objective measures related to changes in the autonomic nervous system. The NoL index&#xD;
           ranges from 0 to 100 and is based on a nonlinear combination of nociception-related&#xD;
           physiologic variables, specifically heart rate, heart rate variability at the 0.15- to&#xD;
           0.4-Hz band power, photoplethysmograph wave amplitude , skin conductance level, number&#xD;
           of skin conductance fluctuations, and their time derivatives.&#xD;
&#xD;
           In the trial the invastigator assume that combination of several parameters into a&#xD;
           single one (Nol Index) may have a stronger association with pain intensity than each of&#xD;
           the parameters alone.&#xD;
&#xD;
           Medasense Biometrics Ltd. developed the PMD-200, a nociception/pain monitor that is&#xD;
           based on a patented, non-invasive technology enabling objective, continuous assessment&#xD;
           of changes in pain level. Information is collected through a finger-mounted probe that&#xD;
           monitors changes in multiple pain-related physiological parameters (pulse rate,&#xD;
           photoplethismograph amplitude, heart rate variability, skin conductance level and number&#xD;
           of skin conductance fluctuations). This information is analyzed using proprietary&#xD;
           artificial intelligence algorithms, which convert the physiological data to a real-time&#xD;
           nociception Index.&#xD;
&#xD;
           The rationale for developing the device is to provide caregivers with the ability to&#xD;
           measure pain level (or nociception level for unconscious patients) during any procedure&#xD;
           and at any time. This information can prevent unnecessary pain, avoid overdose or under&#xD;
           usage of analgesic agents, enhance recovery and decrease hospitalization time and costs,&#xD;
           while answering the critical need to supervise patients' pain/nociception level.&#xD;
&#xD;
           The finger probe sensor of PMD-200 collects the following signals:&#xD;
&#xD;
             1. PhotoPlethysmograph (PPG) - used to optically obtain a volumetric measurement of&#xD;
                the finger's tip blood vessels. The trace is generated by light emitted from a LED&#xD;
                (~780nm) and collected by a photo diode.&#xD;
&#xD;
             2. Galvanic Skin Response (GSR) - used to measure the electrical conductance of the&#xD;
                skin, which varies with its moisture level. The conductance is obtained by&#xD;
                injecting a current between two electrodes placed on the finger and measuring the&#xD;
                voltage.&#xD;
&#xD;
             3. Temperature (TMP) - used to measure the skin temperature using a thermistor.&#xD;
&#xD;
             4. Accelerometer (ACC) - used to measure finger movements The technology consists of&#xD;
                measurements of a number of pain-related physiological parameters that corresponds&#xD;
                with the autonomic nervous system's response to pain, and using the company's&#xD;
                proprietary algorithms, 'translating' these measurements into an index that&#xD;
                represents the pain response, the NoL™ (Nociception Level) Index. This index is&#xD;
                displayed on a bedside monitor.&#xD;
&#xD;
           The measurements taken by the Medasense monitor include galvanic skin response,&#xD;
           photoplethysmography , skin temperature and movement .&#xD;
&#xD;
           All measurements are taken simultaneously using a single finger probe attached to the&#xD;
           patient's finger. Miniature sensors are embedded into the probe, which includes reusable&#xD;
           and single use components. The finger probe is connected to the bedside monitor for&#xD;
           processing of the data.&#xD;
&#xD;
           Operating the PMD-200 monitor is similar to other standard-of-care systems that track&#xD;
           changes in patients' vital functions, such as heart rate, blood pressure or blood oxygen&#xD;
           saturation. Such monitors obtain their information from sensing element(s) attached to&#xD;
           the patient, display the respective clinical values on a bedside, generate relevant&#xD;
           alerts, and maintain records of the information tracked.&#xD;
&#xD;
        2. Methods Population study - electively patients that are going to underwent laparoscopic&#xD;
           cholecystectomy.&#xD;
&#xD;
             1. First measurement will be taken a day before surgery by placing the device on a&#xD;
                patient's 3rd finger for 3-5 minutes in a quiet environment. The measurement will&#xD;
                be the NOL value (baseline) without pain. The patient will be asked to estimate the&#xD;
                pain level using VAS (visual analog scale) score of 0-10.&#xD;
&#xD;
             2. After determining the NOL value, an IV catheter will be inserted, as required&#xD;
                pre-operatively.&#xD;
&#xD;
             3. The device will continue measuring the pain level while the patient will be asked&#xD;
                to estimate the pain level again using VAS .&#xD;
&#xD;
             4. The patient will be operated.&#xD;
&#xD;
             5. The patient will receive post-operative analgesia according to ward protocol - PRN&#xD;
                IV Dipyrone 1g or PRN IV Paracetamol 1g.&#xD;
&#xD;
             6. The device will measure pain from 5 minutes before until 20 minutes after&#xD;
                analgesics administration. During this time VAS score will be taken. This measure&#xD;
                will be taken up to 3 times during the post-operative hospitalization.&#xD;
&#xD;
             7. The measurement will be taken in a quiet environment without distractions. Any&#xD;
                distraction during measurement will be noted as an EVENT.&#xD;
&#xD;
        3. Aims&#xD;
&#xD;
             1. To examine the response of NoL Index in relation to pain&#xD;
&#xD;
             2. To develop objective tool to assess the severity of pain in post-operative patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain level estimation by 1-100 scale by non invasive finger sensor</measure>
    <time_frame>up to 7 months</time_frame>
    <description>a finger sensor will estimate the pain by a numerical scale of 1-100 in which 1 stand for no pain and 100 stand for severe pain.</description>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Pain, Postoperative</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PMD 200</intervention_name>
    <description>finger sensor which estimate objectively the pain level</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-100&#xD;
&#xD;
          -  Elective patient for laparoscopic cholecystectomy&#xD;
&#xD;
          -  Absence of acute or chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Dementia and mental retardation&#xD;
&#xD;
          -  Drugs that influence the autonomic system as beta blocker&#xD;
&#xD;
          -  Arrhythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>haim Paran, MD</last_name>
    <role>Study Chair</role>
    <affiliation>clalit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guy Elad, MD</last_name>
    <phone>972543977953</phone>
    <email>dr.guyelad@gmail.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Hospital, Kfar Saba, Israel</investigator_affiliation>
    <investigator_full_name>Guy Elad</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>post operative</keyword>
  <keyword>surgery</keyword>
  <keyword>objective</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252301
org study id: 0054-17-MMC
nct id: NCT03252301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial will estimate post-operative pain management in elective surgical patients using
      the PMD-200 device. The device measures physiological parameters by placing a non-invasive
      sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level
      will be estimated before surgery (baseline), after surgery and during administration of
      parenteral analgesia. Treatment and analgesia will be given according to clinical
      considerations and standard ward protocols. The device measurements won't influence the
      treatment.
1. Background The key to adequate pain management is assessing its presence, duration and
           severity, identifying those who require intervention, and evaluating the treatment
           efficacy. Pain relates to both the noxious input, via peripheral nerves, and to central
           modulation, thereby, integrating different modalities such as affect, experience or
           personality. Nociception refers to the peripheral and central nervous system (CNS)
           processing of information about the internal or external environment, as generated by
           activation of nociceptors. Typically, noxious stimuli, including tissue injury, activate
           nociceptors that are present in peripheral structures and that transmit information to
           the spinal cord dorsal horn (or its trigeminal homologue - the nucleus caudalis). From
           there, the information continues to the brainstem and ultimately the cerebral cortex,
           where the perception of pain is generated. The pain is a product of higher brain center
           processing, whereas nociception can occur in the absence of pain.

           Objective assessment of nociception poses a multitude of challenges. First, sedated or
           unconscious patients by definition cannot experience pain. Under these circumstances, it
           is more accurate to assess the nociception level. A body of research suggests that not
           managing nociception can lead to central changes in pain pathways that predispose
           individuals to chronic pain states.

           Current "gold-standard" pain assessment tools rely on self-reporting, requiring an
           individual both to process external information and to communicate this personal
           experience.

           Circumstances exist where self-reporting is not possible, or where it is unreliable. In
           these situations, surrogate markers utilize changes in behavioral or physiological
           parameters. However, their use can be associated with considerable shortcomings. They
           may be unreliable, hampered by observational bias, or influenced by disease processes or
           pharmacological interventions. Developing an objective method of pain assessment
           therefore needs to ensure tools that are sensitive and specific to pain. They need to be
           observer-independent, not reliant on the patient's ability to communicate and not
           influenced by disease characteristics.

           A novel measure of nociception is the nociception level (NoL) index. It is based on
           objective measures related to changes in the autonomic nervous system. The NoL index
           ranges from 0 to 100 and is based on a nonlinear combination of nociception-related
           physiologic variables, specifically heart rate, heart rate variability at the 0.15- to
           0.4-Hz band power, photoplethysmograph wave amplitude , skin conductance level, number
           of skin conductance fluctuations, and their time derivatives.

           In the trial the invastigator assume that combination of several parameters into a
           single one (Nol Index) may have a stronger association with pain intensity than each of
           the parameters alone.

           Medasense Biometrics Ltd. developed the PMD-200, a nociception/pain monitor that is
           based on a patented, non-invasive technology enabling objective, continuous assessment
           of changes in pain level. Information is collected through a finger-mounted probe that
           monitors changes in multiple pain-related physiological parameters (pulse rate,
           photoplethismograph amplitude, heart rate variability, skin conductance level and number
           of skin conductance fluctuations). This information is analyzed using proprietary
           artificial intelligence algorithms, which convert the physiological data to a real-time
           nociception Index.

           The rationale for developing the device is to provide caregivers with the ability to
           measure pain level (or nociception level for unconscious patients) during any procedure
           and at any time. This information can prevent unnecessary pain, avoid overdose or under
           usage of analgesic agents, enhance recovery and decrease hospitalization time and costs,
           while answering the critical need to supervise patients' pain/nociception level.

           The finger probe sensor of PMD-200 collects the following signals:

             1. PhotoPlethysmograph (PPG) - used to optically obtain a volumetric measurement of
                the finger's tip blood vessels. The trace is generated by light emitted from a LED
                (~780nm) and collected by a photo diode.

             2. Galvanic Skin Response (GSR) - used to measure the electrical conductance of the
                skin, which varies with its moisture level. The conductance is obtained by
                injecting a current between two electrodes placed on the finger and measuring the
                voltage.

             3. Temperature (TMP) - used to measure the skin temperature using a thermistor.

             4. Accelerometer (ACC) - used to measure finger movements The technology consists of
                measurements of a number of pain-related physiological parameters that corresponds
                with the autonomic nervous system's response to pain, and using the company's
                proprietary algorithms, 'translating' these measurements into an index that
                represents the pain response, the NoL™ (Nociception Level) Index. This index is
                displayed on a bedside monitor.

           The measurements taken by the Medasense monitor include galvanic skin response,
           photoplethysmography , skin temperature and movement .

           All measurements are taken simultaneously using a single finger probe attached to the
           patient's finger. Miniature sensors are embedded into the probe, which includes reusable
           and single use components. The finger probe is connected to the bedside monitor for
           processing of the data.

           Operating the PMD-200 monitor is similar to other standard-of-care systems that track
           changes in patients' vital functions, such as heart rate, blood pressure or blood oxygen
           saturation. Such monitors obtain their information from sensing element(s) attached to
           the patient, display the respective clinical values on a bedside, generate relevant
           alerts, and maintain records of the information tracked.

        2. Methods Population study - electively patients that are going to underwent laparoscopic
           cholecystectomy.

             1. First measurement will be taken a day before surgery by placing the device on a
                patient's 3rd finger for 3-5 minutes in a quiet environment. The measurement will
                be the NOL value (baseline) without pain. The patient will be asked to estimate the
                pain level using VAS (visual analog scale) score of 0-10.

             2. After determining the NOL value, an IV catheter will be inserted, as required
                pre-operatively.

             3. The device will continue measuring the pain level while the patient will be asked
                to estimate the pain level again using VAS .

             4. The patient will be operated.

             5. The patient will receive post-operative analgesia according to ward protocol - PRN
                IV Dipyrone 1g or PRN IV Paracetamol 1g.

             6. The device will measure pain from 5 minutes before until 20 minutes after
                analgesics administration. During this time VAS score will be taken. This measure
                will be taken up to 3 times during the post-operative hospitalization.

             7. The measurement will be taken in a quiet environment without distractions. Any
                distraction during measurement will be noted as an EVENT.

        3. Aims

             1. To examine the response of NoL Index in relation to pain

             2. To develop objective tool to assess the severity of pain in post-operative patient.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: pain level estimation by 1-100 scale by non invasive finger sensor
time frame: up to 7 months
description: a finger sensor will estimate the pain by a numerical scale of 1-100 in which 1 stand for no pain and 100 stand for severe pain.
intervention type: Device
intervention name: PMD 200
description: finger sensor which estimate objectively the pain level
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: haim Paran, MD
role: Study Chair
affiliation: clalit
last name: Guy Elad, MD
phone: 972543977953
email: dr.guyelad@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Meir Hospital, Kfar Saba, Israel
investigator full name: Guy Elad
investigator title: principal investigator
mesh term: Pain, Postoperative
sharing ipd: No