<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/NCT04406740</url>
  </required_header>
  <id_info>
    <org_study_id>ANES-2020-28905</org_study_id>
    <nct_id>NCT04406740</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System</brief_title>
  <official_title>Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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 study is designed to formally evaluate the performance of the QTOF, as compared with the&#xD;
      newest commercially available NMB monitoring equipment, EMG (the TwitchView).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The disposable stimulus/recording electrode array for the TwitchView will be placed on one of&#xD;
      the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and&#xD;
      vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and&#xD;
      thenar eminence. The devices will be placed prior to the induction of anesthesia - but no&#xD;
      electrical stimuli will be delivered until AFTER the patient is asleep (as per routine).&#xD;
      After induction, both devices will be started. The TwitchView automatically selects the&#xD;
      appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF&#xD;
      stimulus current will be set to the same value. The stimulus interval for both devices will&#xD;
      be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the&#xD;
      entirety of the surgical procedure, and cross checked with Epic regarding the administration&#xD;
      of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be&#xD;
      present to verify the correct function of both devices. Note that information from the&#xD;
      TwitchView monitor will be continuous available to the providers (it is a standard device&#xD;
      available for use in our ORs). Information from the QTOF will NOT be made available to&#xD;
      providers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Device malfunction&#xD;
  </why_stopped>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Train-of-Four (TOF) Ratio</measure>
    <time_frame>420 minutes</time_frame>
    <description>The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">9</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <description>Adult patients &gt;18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TwitchView EMG Unit</intervention_name>
    <description>The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Novel QTOF Device</intervention_name>
    <description>The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients &gt;18 years of age, who are scheduled to undergo any elective procedure under&#xD;
        general anesthesia in the MHealth East Bank operating rooms in which the administration of&#xD;
        a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients scheduled to undergo any elective procedure under general anesthesia in the&#xD;
        MHealth East Bank operating rooms in which the administration of a nondepolarizing&#xD;
        neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergent procedures will be excluded&#xD;
&#xD;
          -  Procedures performed outside of regular Monday to Friday working hours will be&#xD;
             excluded&#xD;
&#xD;
          -  Inability to provide their own consent&#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>Michael Todd, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MHealth Farview University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</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>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04406740
org study id: ANES-2020-28905
nct id: NCT04406740
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is designed to formally evaluate the performance of the QTOF, as compared with the
      newest commercially available NMB monitoring equipment, EMG (the TwitchView).
The disposable stimulus/recording electrode array for the TwitchView will be placed on one of
      the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and
      vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and
      thenar eminence. The devices will be placed prior to the induction of anesthesia - but no
      electrical stimuli will be delivered until AFTER the patient is asleep (as per routine).
      After induction, both devices will be started. The TwitchView automatically selects the
      appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF
      stimulus current will be set to the same value. The stimulus interval for both devices will
      be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the
      entirety of the surgical procedure, and cross checked with Epic regarding the administration
      of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be
      present to verify the correct function of both devices. Note that information from the
      TwitchView monitor will be continuous available to the providers (it is a standard device
      available for use in our ORs). Information from the QTOF will NOT be made available to
      providers.
observational model: Cohort
time perspective: Prospective
measure: Train-of-Four (TOF) Ratio
time frame: 420 minutes
description: The train-of-four ratio (unitless measure) is calculated by comparing the magnitude of the fourth evoked response or twitch (T4) to that of the first response (T1).
arm group label: All Participants
description: Adult patients >18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.
intervention type: Device
intervention name: TwitchView EMG Unit
description: The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.
arm group label: All Participants
intervention type: Device
intervention name: Novel QTOF Device
description: The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).
arm group label: All Participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Todd, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided