<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/NCT03778749</url>
  </required_header>
  <id_info>
    <org_study_id>2018/091</org_study_id>
    <nct_id>NCT03778749</nct_id>
  </id_info>
  <brief_title>Electromyography and Acceleromyography in Ventilated ICU Patients</brief_title>
  <official_title>The Effectiveness of Electromyographic- and Acceleromyographic-based Monitors in Diagnosing Pre-existing Train-of-four Fade in Ventilated ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Onze Lieve Vrouw Hospital</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>
      In intensive care unit (ICU) patients who are mechanically ventilated for a longer period of&#xD;
      time, there might be a difference in accuracy and performance of neuromuscular transmission&#xD;
      monitoring [as measured by the train-of-four (TOF)%] due to a pre-existing TOF fade,&#xD;
      correlated to some form of acquired muscle weakness. The investigators therefore propose to&#xD;
      search for and compare the optimal monitoring techniques (acceleromyography vs.&#xD;
      electromyography) and the optimal muscle monitoring site (peripheral-adductor pollicis vs.&#xD;
      central-corrugator supercilii) in ICU patients who require prolonged mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following neuromuscular transmission monitors will be used in the study: an&#xD;
      electromyography-based monitor (TetraGraph, Senzime AB, Uppsala, Sweden) and two devices that&#xD;
      are the newer generation of quantitative monitoring using three-dimensional&#xD;
      acceleromyographic technology: Stimpod (Xavant Technology, Pretoria, South Africa) and&#xD;
      TofScan (IDmed, Marseilles, France), both of which require minimal setup for use.&#xD;
&#xD;
      The stimulation pattern of both ulnar and facial nerves will be train-of-four (TOF) delivered&#xD;
      every 1 minute, and the mean of three consecutive measurements will be calculated as the TOF%&#xD;
      for that patient. Patients will be tested every 24 hrs, once a day, at the same time, over&#xD;
      the 72 hrs the study will take place in the ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Application of monitoring tools seemed inappropriate in ICU patients who were ventilated during&#xD;
    a prolonged period.&#xD;
  </why_stopped>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</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>
    <intervention_model_description>Twenty mechanically ventilated ICU patients: the investigators will compare the mean TOF% between three different measurement techniques in 20 mechanically ventilated ICU patients: 1/electromyographic neuromuscular transmission monitoring at the hand muscle - 2/acceleromyographic neuromuscular transmission monitoring at the hand muscle - 3/acceleromyographic neuromuscular transmission monitoring at the eyebrow muscle; and the investigators will determine how the three TOF% values vary in each individual patient.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pre-existing neuromuscular fade (TOF% &lt;90), correlated to some form of ICU acquired muscle weakness, in ICU patients mechanically ventilated for more than 72 hrs.</measure>
    <time_frame>72 hours of study period in ICU</time_frame>
    <description>to find whether any patients show any pre-existing neuromuscular fade or develop such weakness over the 72 hours of study period in ICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fade (TOF% &lt;90) difference between central (corrugator supercilii) and peripheral (adductor pollicis) muscles in ICU patients who require prolonged mechanical ventilation.</measure>
    <time_frame>72 hours of study period in ICU</time_frame>
    <description>to compare the development of fade (if any develops) between central and peripheral muscles over the 72 hours of study period in ICU</description>
  </secondary_outcome>
  <other_outcome>
    <measure>optimal monitor for use in the ICU setting</measure>
    <time_frame>72 hours of study period in ICU</time_frame>
    <description>to determine the TOF% repeatability of the three monitors, establishing the optimal monitor for use in the ICU setting</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Neuromuscular Monitoring</condition>
  <arm_group>
    <arm_group_label>electromyographic NMT monitoring at the hand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acceleromyographic NMT monitoring at the hand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acceleromyographic NMT monitoring at the eyebrow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TOF measurements</intervention_name>
    <description>The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.</description>
    <arm_group_label>acceleromyographic NMT monitoring at the eyebrow</arm_group_label>
    <arm_group_label>acceleromyographic NMT monitoring at the hand</arm_group_label>
    <arm_group_label>electromyographic NMT monitoring at the hand</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 yr. old or older&#xD;
&#xD;
          -  expected to require mechanical ventilation for more than 72 hrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  degenerative neurological disease&#xD;
&#xD;
          -  receive drugs interfering with NMT (e.g., aminoglycosides or magnesium)&#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>Guy Cammu, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OLV Hospital</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.</citation>
    <PMID>28044330</PMID>
  </reference>
  <reference>
    <citation>Cammu G, Neyens E, Coddens J, Van Praet F, De Decker K. Postoperative residual curarisation is still an issue when weaning patients in intensive care following cardiac surgery. Anaesth Intensive Care. 2018 Nov;46(6):634-636. No abstract available.</citation>
    <PMID>30447682</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Onze Lieve Vrouw Hospital</investigator_affiliation>
    <investigator_full_name>Guy CAMMU</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>train-of-four monitoring</keyword>
  <keyword>acceleromyography</keyword>
  <keyword>electromyography</keyword>
  <keyword>intensive care unit</keyword>
  <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/NCT03778749
org study id: 2018/091
nct id: NCT03778749
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In intensive care unit (ICU) patients who are mechanically ventilated for a longer period of
      time, there might be a difference in accuracy and performance of neuromuscular transmission
      monitoring [as measured by the train-of-four (TOF)%] due to a pre-existing TOF fade,
      correlated to some form of acquired muscle weakness. The investigators therefore propose to
      search for and compare the optimal monitoring techniques (acceleromyography vs.
      electromyography) and the optimal muscle monitoring site (peripheral-adductor pollicis vs.
      central-corrugator supercilii) in ICU patients who require prolonged mechanical ventilation.
The following neuromuscular transmission monitors will be used in the study: an
      electromyography-based monitor (TetraGraph, Senzime AB, Uppsala, Sweden) and two devices that
      are the newer generation of quantitative monitoring using three-dimensional
      acceleromyographic technology: Stimpod (Xavant Technology, Pretoria, South Africa) and
      TofScan (IDmed, Marseilles, France), both of which require minimal setup for use.

      The stimulation pattern of both ulnar and facial nerves will be train-of-four (TOF) delivered
      every 1 minute, and the mean of three consecutive measurements will be calculated as the TOF%
      for that patient. Patients will be tested every 24 hrs, once a day, at the same time, over
      the 72 hrs the study will take place in the ICU.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Twenty mechanically ventilated ICU patients: the investigators will compare the mean TOF% between three different measurement techniques in 20 mechanically ventilated ICU patients: 1/electromyographic neuromuscular transmission monitoring at the hand muscle - 2/acceleromyographic neuromuscular transmission monitoring at the hand muscle - 3/acceleromyographic neuromuscular transmission monitoring at the eyebrow muscle; and the investigators will determine how the three TOF% values vary in each individual patient.
primary purpose: Diagnostic
masking: None (Open Label)
measure: pre-existing neuromuscular fade (TOF% <90), correlated to some form of ICU acquired muscle weakness, in ICU patients mechanically ventilated for more than 72 hrs.
time frame: 72 hours of study period in ICU
description: to find whether any patients show any pre-existing neuromuscular fade or develop such weakness over the 72 hours of study period in ICU
measure: fade (TOF% <90) difference between central (corrugator supercilii) and peripheral (adductor pollicis) muscles in ICU patients who require prolonged mechanical ventilation.
time frame: 72 hours of study period in ICU
description: to compare the development of fade (if any develops) between central and peripheral muscles over the 72 hours of study period in ICU
measure: optimal monitor for use in the ICU setting
time frame: 72 hours of study period in ICU
description: to determine the TOF% repeatability of the three monitors, establishing the optimal monitor for use in the ICU setting
arm group label: electromyographic NMT monitoring at the hand
arm group type: Experimental
description: In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.
arm group label: acceleromyographic NMT monitoring at the hand
arm group type: Experimental
description: In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.
arm group label: acceleromyographic NMT monitoring at the eyebrow
arm group type: Experimental
description: In 20 mechanically ventilated ICU patients, TOF measurements will be performed every 24 hrs, once a day, at the same time, over the 72 hrs the study will take place in the ICU.
intervention type: Diagnostic Test
intervention name: TOF measurements
description: The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.
arm group label: acceleromyographic NMT monitoring at the eyebrow
arm group label: acceleromyographic NMT monitoring at the hand
arm group label: electromyographic NMT monitoring at the hand
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guy Cammu, MD,PhD
role: Principal Investigator
affiliation: Onze-Lieve-Vrouw Ziekenhuis, Aalst, Belgium
facility: 
country: Belgium
citation: Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
PMID: 28044330
citation: Cammu G, Neyens E, Coddens J, Van Praet F, De Decker K. Postoperative residual curarisation is still an issue when weaning patients in intensive care following cardiac surgery. Anaesth Intensive Care. 2018 Nov;46(6):634-636. No abstract available.
PMID: 30447682
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Guy CAMMU
investigator title: Principal Investigator
sharing ipd: Undecided