<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/NCT04475250</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001075</org_study_id>
    <nct_id>NCT04475250</nct_id>
  </id_info>
  <brief_title>Train-of-four Monitoring Using the Tetragraph</brief_title>
  <official_title>Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph D. Tobias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study that will evaluate the feasibility of using the Tetragraph&#xD;
      Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four&#xD;
      assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EMG changes</measure>
    <time_frame>During the surgery</time_frame>
    <description>Changes in the amplitude of the evoked response of the muscles.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Tetragraph</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tetragraph (TM) NMT Monitor</intervention_name>
    <description>TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.</description>
    <arm_group_label>Tetragraph</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients requiring anesthetic care and use of neuromuscular blockade&#xD;
&#xD;
          -  Weight range of 20 - 60 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of a peripheral neurologic or neuropathic disorder&#xD;
&#xD;
          -  Patients in whom the upper extremity cannot be used for TOF monitoring&#xD;
&#xD;
          -  Patients undergoing a surgical procedure in which neuromuscular blockade is not&#xD;
             required&#xD;
&#xD;
          -  Edematous patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>February 6, 2023</last_update_submitted>
  <last_update_submitted_qc>February 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Joseph D. Tobias</investigator_full_name>
    <investigator_title>Chairman, Dept. of Anesthesiology &amp; Pain Medicine</investigator_title>
  </responsible_party>
  <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/NCT04475250
org study id: STUDY00001075
nct id: NCT04475250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a prospective study that will evaluate the feasibility of using the Tetragraph
      Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four
      assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: EMG changes
time frame: During the surgery
description: Changes in the amplitude of the evoked response of the muscles.
arm group label: Tetragraph
arm group type: Experimental
intervention type: Device
intervention name: Tetragraph (TM) NMT Monitor
description: TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
arm group label: Tetragraph
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Joseph D. Tobias
investigator title: Chairman, Dept. of Anesthesiology & Pain Medicine
sharing ipd: No