<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/NCT02241304</url>
  </required_header>
  <id_info>
    <org_study_id>ADBV-ABS-0214-NEAT-3H</org_study_id>
    <secondary_id>028605/2014/OTIG</secondary_id>
    <secondary_id>DE RKEB/IKEB 4170-2014</secondary_id>
    <nct_id>NCT02241304</nct_id>
  </id_info>
  <brief_title>Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)</brief_title>
  <acronym>NEAT-3</acronym>
  <official_title>Neurostimulation and Electromyographic Assessment of the TetraGraph (NEAT) In Patients (NEAT-3)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Debrecen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Debrecen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular&#xD;
      monitoring system intended for daily clinical use. The primary aim of this clinical&#xD;
      investigation is to examine the applicability (ease of use, equipment need, etc.),&#xD;
      repeatability (precision or internal consistency) and performance (signal quality, accuracy&#xD;
      of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph&#xD;
      device in patients undergoing elective surgeries requiring neuromuscular blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries&#xD;
      requiring neuromuscular blockade. The left of right hand of the patients will be randomly&#xD;
      studied. After the induction of anesthesia but before the administration of muscle relaxant&#xD;
      train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse&#xD;
      duration at 20 sec intervals. The stimulation will be left to run until extubation. The&#xD;
      TetraGraph device will be set not to show measurement results on the screen but save them on&#xD;
      the SD card for later analysis. This way TetraGraph will not influence clinical decisions and&#xD;
      patient care. During the operations we will record the number of muscle twitches in return to&#xD;
      stimulation, the time and dose of muscle relaxant and opioid administration, the time of use&#xD;
      of electrocautery and the skin temperature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary performance assessment of TetraGraph device</measure>
    <time_frame>participants will be followed for the duration of their hospital stay, an expected avarage of five days</time_frame>
    <description>The primary objective of this study is to provide safety &amp; performance data of the TetraGraph device in anesthetized patients. Performance will be assessed post hoc by analyzing objective EMG data from the SD card and correlating the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA or reversal agent administration). No clinical decisions will be made based on any objective measurements made by the TetraGraph. There are no specific timepoints concerning the primary outcome measure of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary performance assessment of TetraGraph Device</measure>
    <time_frame>participants will be followed for the duration of the hospital stay, an expected avarage of 5 days</time_frame>
    <description>The secondary outcome measures is a composite of several safety and performance data examined during the operations and the hospital stay:&#xD;
Acceptable levels of electrical noise when no stimulus is being applied;&#xD;
Ensuring that the stimulus artifact does not obscure the EMG response when a stimulus is applied;&#xD;
Appearance of an EMG response at threshold stimulation levels, just sufficient to elicit a palpable twitch response;&#xD;
Consistency of the EMG response amplitudes during repeated (ST and TOF) protocols (variability &lt;10%);&#xD;
Consistency of EMG response characteristics independent of patient age, gender, or weight;&#xD;
Consistency of EMG response characteristics independent whether the right or left arm is stimulated;&#xD;
Skin reaction to stimulation or recording electrodes;&#xD;
Overall usability of the device for clinicians and operators; collecting recommendations for improving ease of use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of TetraGraph device</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected avarage of 5 days</time_frame>
    <description>The safety of Tetragraph device will be assesses by checking the stimulating and recording electrode positions for skin reactions.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>Elective surgery with muscle relaxation</arm_group_label>
    <description>ASA I-II-III patients. Fentanyl (2-3 ug/kg) - Propofol (2 mg/kg) induction, sevoflurane anesthesia, type and dose of muscle relaxant up to the decision of attending anesthetist. Neuromuscular stimulation with TetraGraph (30mA current intensity, 0.2 msce pulse duration, 20 sec intervals)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective surgeries requiring muscle relaxation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older.&#xD;
&#xD;
          2. American Society of Anesthesiology (ASA) physical status I-III criteria (Table I).&#xD;
&#xD;
          3. Subject has provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of an underlying neuromuscular disease.&#xD;
&#xD;
          2. Presence of renal or hepatic disease.&#xD;
&#xD;
          3. Subject has open skin sores in the locations needed for electrode application&#xD;
             (forearms).&#xD;
&#xD;
          4. Patient is taking anti-seizure medication&#xD;
&#xD;
          5. Patient is taking oral anti-cholinesterase (e.g., therapy for myasthenia gravis)&#xD;
&#xD;
          6. Magnesium sulfate administration is required&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bela Fulesdi, MD,PhD,DSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Debrecen</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <citation>1. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002;46:207-13. 2. Berg H, Viby-Mogensen J, Roed J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Acta Anaesthesiol Scand 1997;41:1095-103. 3. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Anesth Analg 2008;107:130-7. 4. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Anesthesiology 2008;109:389-98. 5. Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Anesthesiology 2011;115:946-54. 6. Murphy GS, Brull SJ. Anesth Analg 2010;111:120-8. 7. Hemmerling TM, Le N. Can J Anesth 2007;54: 58-72. 8. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002; 46: 207-13. 9. Brull SJ, Silverman DG. Anesth Analg 1993;77:352-5. 10. Grayling M, Sweeney BP. Anaesthesia 2007; 62:806-9. 11. Liang SS, Stewart PA, Phillips S. Anesth Analg 2013;117:373-9.</citation>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Debrecen</investigator_affiliation>
    <investigator_full_name>Tamas Vegh, MD</investigator_full_name>
    <investigator_title>MD, PHD</investigator_title>
  </responsible_party>
  <keyword>electromyography</keyword>
  <keyword>neuromuscular blockade</keyword>
  <!-- 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/NCT02241304
org study id: ADBV-ABS-0214-NEAT-3H
secondary id: 028605/2014/OTIG
secondary id: DE RKEB/IKEB 4170-2014
nct id: NCT02241304
lead sponsor: 
has dmc: Yes
TetraGraph is a newly developed EMG-based, quantitative, battery-powered neuromuscular
      monitoring system intended for daily clinical use. The primary aim of this clinical
      investigation is to examine the applicability (ease of use, equipment need, etc.),
      repeatability (precision or internal consistency) and performance (signal quality, accuracy
      of outcome, voltage of stimulation output before and during a stimulus) of the Tetragraph
      device in patients undergoing elective surgeries requiring neuromuscular blockade.
The TetraGraph will be tested in 50 consenting patients undergiong elective surgeries
      requiring neuromuscular blockade. The left of right hand of the patients will be randomly
      studied. After the induction of anesthesia but before the administration of muscle relaxant
      train-of-four (TOF) stimulation will be started with 30 mA current intensity, 0.2 msec pulse
      duration at 20 sec intervals. The stimulation will be left to run until extubation. The
      TetraGraph device will be set not to show measurement results on the screen but save them on
      the SD card for later analysis. This way TetraGraph will not influence clinical decisions and
      patient care. During the operations we will record the number of muscle twitches in return to
      stimulation, the time and dose of muscle relaxant and opioid administration, the time of use
      of electrocautery and the skin temperature.
observational model: Cohort
time perspective: Prospective
measure: Primary performance assessment of TetraGraph device
time frame: participants will be followed for the duration of their hospital stay, an expected avarage of five days
description: The primary objective of this study is to provide safety & performance data of the TetraGraph device in anesthetized patients. Performance will be assessed post hoc by analyzing objective EMG data from the SD card and correlating the responses to annotations made during the surgical procedure (e.g., correlating the EMG responses to the time of NMBA or reversal agent administration). No clinical decisions will be made based on any objective measurements made by the TetraGraph. There are no specific timepoints concerning the primary outcome measure of the study.
measure: Secondary performance assessment of TetraGraph Device
time frame: participants will be followed for the duration of the hospital stay, an expected avarage of 5 days
description: The secondary outcome measures is a composite of several safety and performance data examined during the operations and the hospital stay:
Acceptable levels of electrical noise when no stimulus is being applied;
Ensuring that the stimulus artifact does not obscure the EMG response when a stimulus is applied;
Appearance of an EMG response at threshold stimulation levels, just sufficient to elicit a palpable twitch response;
Consistency of the EMG response amplitudes during repeated (ST and TOF) protocols (variability <10%);
Consistency of EMG response characteristics independent of patient age, gender, or weight;
Consistency of EMG response characteristics independent whether the right or left arm is stimulated;
Skin reaction to stimulation or recording electrodes;
Overall usability of the device for clinicians and operators; collecting recommendations for improving ease of use.
measure: Safety of TetraGraph device
time frame: participants will be followed for the duration of hospital stay, an expected avarage of 5 days
description: The safety of Tetragraph device will be assesses by checking the stimulating and recording electrode positions for skin reactions.
arm group label: Elective surgery with muscle relaxation
description: ASA I-II-III patients. Fentanyl (2-3 ug/kg) - Propofol (2 mg/kg) induction, sevoflurane anesthesia, type and dose of muscle relaxant up to the decision of attending anesthetist. Neuromuscular stimulation with TetraGraph (30mA current intensity, 0.2 msce pulse duration, 20 sec intervals)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bela Fulesdi, MD,PhD,DSci
role: Principal Investigator
affiliation: UNIVERSITY OF DEBRECEN FACULTY OF MEDICINE Department of Anesthesiology and Intensive Care Debrecen, Hungary, 4032
facility: 
country: Hungary
citation: 1. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002;46:207-13. 2. Berg H, Viby-Mogensen J, Roed J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Acta Anaesthesiol Scand 1997;41:1095-103. 3. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Anesth Analg 2008;107:130-7. 4. Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Nisman M. Anesthesiology 2008;109:389-98. 5. Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Vender JS, Gray J, Landry E, Gupta DK. Anesthesiology 2011;115:946-54. 6. Murphy GS, Brull SJ. Anesth Analg 2010;111:120-8. 7. Hemmerling TM, Le N. Can J Anesth 2007;54: 58-72. 8. Gätke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Acta Anaesthesiol Scand 2002; 46: 207-13. 9. Brull SJ, Silverman DG. Anesth Analg 1993;77:352-5. 10. Grayling M, Sweeney BP. Anaesthesia 2007; 62:806-9. 11. Liang SS, Stewart PA, Phillips S. Anesth Analg 2013;117:373-9.
responsible party type: Principal Investigator
investigator affiliation: University of Debrecen
investigator full name: Tamas Vegh, MD
investigator title: MD, PHD