<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/NCT03276260</url>
  </required_header>
  <id_info>
    <org_study_id>CLI-17-02</org_study_id>
    <nct_id>NCT03276260</nct_id>
  </id_info>
  <brief_title>Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care</brief_title>
  <official_title>Evaluation of Medasense's PMD-200 During Surgery and Post Anesthesia Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medasense Biometrics Ltd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medasense Biometrics Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone,&#xD;
      continuous monitor that is designed to provide real-time information about changes in the&#xD;
      nociception level of patients under general anesthesia during surgical procedures.&#xD;
&#xD;
      The PMD-200 System is based on real-time data acquisition and processing of physiological&#xD;
      signals. The system displays the NOL index (a single numerical index) which is computed from&#xD;
      recorded physiological parameters based on a proprietary algorithm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this observational study is to evaluate the pattern of the NOL index during&#xD;
      surgery in the anesthetized patient and during the post-operative period in the awake&#xD;
      patient.&#xD;
&#xD;
      Up to 100 patients scheduled for elective surgery under general, regional and local&#xD;
      anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will&#xD;
      be enrolled after signing informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI decided not to continue&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.</measure>
    <time_frame>At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity and sensitivity of the NOL index for detecting nociception as evaluated by receiver operating characteristics curve (ROC) analysis.</measure>
    <time_frame>At time of surgery, between the anaesthesia induction and extubation.</time_frame>
    <description>The calculated area under the graph of change in NOL values in response to a painful stimulus, as mentioned in Outcome 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.</measure>
    <time_frame>At time of surgery: pre-defined non noxious period - a period of 2 minutes with no noxious event with a minimal time period of 3 min prior and following laryngoscopy and intubation, skin incision or first trocar insertion.</time_frame>
    <description>Pre-defined noxious events - laryngoscopy and intubation, skin incision or first trocar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in NOL index in response to administration of analgesics.</measure>
    <time_frame>At time of surgery, 1min before versus 1 min after administration of analgesics drugs.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.</measure>
    <time_frame>At time of surgery, between the anaesthesia induction and extubation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total time with mean arterial pressure (MAP) &lt; 65 mmHg and correlation to NOL values during surgery and anaesthesia.</measure>
    <time_frame>At time of surgery, between the anaesthesia induction and extubation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total analgesics administration during PACU (arrival to discharge) and frequency of administration</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NOL values during stay in PACU in the awake patient (arrival to discharge)</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
    <description>The NOL will be calculated via the investigational device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' NRS (numerical rating scale ) values during stay in PACU (arrival to discharge).</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
    <description>NRS will be recorded every 15 min in the PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation scores during stay in PACU (arrival to discharge).</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
    <description>Sedation scores will be recorded every 30 min in the PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesic request or administration in PACU.</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of opioid adverse effects in PACU (nausea and vomiting, pruritus, desaturation, respiratory depression, apnea).</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of readiness to discharge from PACU</measure>
    <time_frame>Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.</time_frame>
    <description>This time will be recorded since it may be different from the actual time of discharge which may be prolonged due to non-medical reasons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between NOL values during surgery and anesthesia to NOL values during the post-operative period.</measure>
    <time_frame>From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.</time_frame>
    <description>The NOL will be calculated via the investigational device.</description>
  </secondary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Surgery</condition>
  <condition>Nociceptive Pain</condition>
  <condition>Postoperative Pain</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PMD-200</intervention_name>
    <description>Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 100 patients scheduled for elective surgery under general, regional and local&#xD;
        anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria,&#xD;
        will be enrolled after signing informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Age 18 - 75 years&#xD;
&#xD;
          -  ASA physical status 1-3&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe cardiac arrhythmia&#xD;
&#xD;
          -  Abuse of alcohol or illicit drugs&#xD;
&#xD;
          -  Preoperative opioid consumption for &gt; 1 week&#xD;
&#xD;
          -  History of mental retardation or any mental disease diagnosis&#xD;
&#xD;
          -  Under sedation protocol - Patients with difficult spontaneous ventilation ( for e.g.&#xD;
             patients with sleep apnea) will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Edry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.</citation>
    <PMID>27171828</PMID>
  </reference>
  <reference>
    <citation>Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.</citation>
    <PMID>26154185</PMID>
  </reference>
  <reference>
    <citation>Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.</citation>
    <PMID>22647429</PMID>
  </reference>
  <reference>
    <citation>Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.</citation>
    <PMID>23835792</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nociceptive Pain</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/NCT03276260
org study id: CLI-17-02
nct id: NCT03276260
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Medasense's Pain Monitoring Device (PMD) is a novel non-invasive, bedside stand alone,
      continuous monitor that is designed to provide real-time information about changes in the
      nociception level of patients under general anesthesia during surgical procedures.

      The PMD-200 System is based on real-time data acquisition and processing of physiological
      signals. The system displays the NOL index (a single numerical index) which is computed from
      recorded physiological parameters based on a proprietary algorithm.
The aim of this observational study is to evaluate the pattern of the NOL index during
      surgery in the anesthetized patient and during the post-operative period in the awake
      patient.

      Up to 100 patients scheduled for elective surgery under general, regional and local
      anesthesia and sedation, who meet all the inclusion and none of the exclusion criteria, will
      be enrolled after signing informed consent.
observational model: Cohort
time perspective: Cross-Sectional
measure: The ability of NOL index to change in response to noxious and non noxious stimuli as well as in response to analgesic administration.
time frame: At time of surgery. 1 minute before and 1 minute after painful stimuli (for instance: intubation, skin incision, trocar insertion
measure: Specificity and sensitivity of the NOL index for detecting nociception as evaluated by receiver operating characteristics curve (ROC) analysis.
time frame: At time of surgery, between the anaesthesia induction and extubation.
description: The calculated area under the graph of change in NOL values in response to a painful stimulus, as mentioned in Outcome 1.
measure: The change in NOL Index in response to pre-defined non noxious and noxious stimuli during surgery in the anesthetized patient.
time frame: At time of surgery: pre-defined non noxious period - a period of 2 minutes with no noxious event with a minimal time period of 3 min prior and following laryngoscopy and intubation, skin incision or first trocar insertion.
description: Pre-defined noxious events - laryngoscopy and intubation, skin incision or first trocar.
measure: The change in NOL index in response to administration of analgesics.
time frame: At time of surgery, 1min before versus 1 min after administration of analgesics drugs.
measure: Total fentanyl administration during surgery and anaesthesia and frequency of bolus administration.
time frame: At time of surgery, between the anaesthesia induction and extubation.
measure: Total time with mean arterial pressure (MAP) < 65 mmHg and correlation to NOL values during surgery and anaesthesia.
time frame: At time of surgery, between the anaesthesia induction and extubation.
measure: Total analgesics administration during PACU (arrival to discharge) and frequency of administration
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
measure: NOL values during stay in PACU in the awake patient (arrival to discharge)
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
description: The NOL will be calculated via the investigational device.
measure: Patients' NRS (numerical rating scale ) values during stay in PACU (arrival to discharge).
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
description: NRS will be recorded every 15 min in the PACU
measure: Sedation scores during stay in PACU (arrival to discharge).
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
description: Sedation scores will be recorded every 30 min in the PACU
measure: Time to first analgesic request or administration in PACU.
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
measure: Number of opioid adverse effects in PACU (nausea and vomiting, pruritus, desaturation, respiratory depression, apnea).
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
measure: Time of readiness to discharge from PACU
time frame: Throughout PACU (Post Anesthesia Care Unit) stay, between entering PACU to discharge, an average of 2.5 hours.
description: This time will be recorded since it may be different from the actual time of discharge which may be prolonged due to non-medical reasons.
measure: The correlation between NOL values during surgery and anesthesia to NOL values during the post-operative period.
time frame: From the anaesthesia induction till the discharge from the PACU, an average of 5-6 hours.
description: The NOL will be calculated via the investigational device.
intervention type: Device
intervention name: PMD-200
description: Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ruth Edry, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
citation: Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
PMID: 27171828
citation: Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.
PMID: 26154185
citation: Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
PMID: 22647429
citation: Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PMID: 23835792
responsible party type: Sponsor
mesh term: Nociceptive Pain
sharing ipd: No