xml: <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/NCT05992090</url>
    </required_header>
    <id_info>
      <org_study_id>EMG vs KMG</org_study_id>
      <nct_id>NCT05992090</nct_id>
    </id_info>
    <brief_title>Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.</brief_title>
    <official_title>Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.</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>
        This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography&#xD;
        and Electromyography.&#xD;
  &#xD;
        The main questions to answer are:&#xD;
  &#xD;
          -  are electromyography and kine-myography interchangeable&#xD;
  &#xD;
          -  is electromyography linked to fewer fault results&#xD;
  &#xD;
          -  is electromyography using lower energy to stimulate nerves&#xD;
  &#xD;
        The type of study is a multicentric observational clinical trial. Subjects are patients&#xD;
        undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient,&#xD;
        the neuromuscular blockade will be monitored using kine-myograph and electromyography&#xD;
        simultaneously.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Informed consent will first be obtained from the patient for inclusion in the study. Consent&#xD;
        will be obtained during an examination by the anaesthesiologist providing anaesthetic care&#xD;
        during surgery in the anteroom of the operating theatre.&#xD;
  &#xD;
        Once informed consent has been obtained, a routine orientation examination will be performed&#xD;
        by the anaesthetist and routine pre-operative preparation (provision of peripheral venous&#xD;
        access, risk assessment for airway obstruction, etc.) will be performed. The patient will&#xD;
        then be transported to the operating theatre.&#xD;
  &#xD;
        In the operating room, patient monitoring will be initiated, including the deployment of&#xD;
        sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the&#xD;
        right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb&#xD;
        fixation will be performed by the anaesthetic nurse. The fixation will be performed with&#xD;
        splints compatible with the operating table. Fixation of the limbs and sensor with adhesive&#xD;
        tape will not be used.&#xD;
  &#xD;
        The anaesthesia will then be induced. Propofol and sufentanil will be administered at the&#xD;
        discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation&#xD;
        has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade&#xD;
        will be performed. After calibration of the sensors, the supramaximal current to the CRF will&#xD;
        be recorded. The measurement interval will be set to 20 s. After securing the airway, the&#xD;
        interval will be extended to 5 - 15 min according to the nature of the surgery and the&#xD;
        discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT)&#xD;
        and the Train Of Four (TOF) value will be recorded throughout the procedure.&#xD;
  &#xD;
        On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once&#xD;
        sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring&#xD;
        of the depth of neuromuscular blockade will be discontinued.&#xD;
  &#xD;
        If during the measurement of the depth of neuromuscular blockade a value is measured that is&#xD;
        highly suspected to be in error, this suspicion will be recorded in the CRF with a&#xD;
        justification.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</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>Measurement variability</measure>
      <time_frame>From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.</time_frame>
      <description>A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>supramaximal electric stimulus</measure>
      <time_frame>From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.</time_frame>
      <description>A secondary aim is to demonstrate that measuring the depth of neuromuscular blockade using kinemyography is associated with a higher supramaximal electric stimulus than measuring the depth of neuromuscular blockade using electromyography.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TOF overestimation</measure>
      <time_frame>From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.</time_frame>
      <description>The primary objective of the study is to demonstrate that there is measured higher TOF when using KMG to monitor the depth of neuromuscular blockade compared to using EMG sensor to monitor the depth of neuromuscular blockade.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Neuromuscular Blockade</condition>
    <condition>Residual Neuromuscular Blockade</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be selected from residents of the Northern Bohemia region. All&#xD;
          included patients will be indicated for surgery in general anesthesia with the need for&#xD;
          neuromuscular blockade. All selected patients will be hospitalized at Masaryk Hospital in&#xD;
          Ústí nad Labem.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients undergoing surgery under general anaesthesia with the use of cis-atracurium&#xD;
               or rocuronium&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients suffering from neuromuscular diseases&#xD;
  &#xD;
            -  patients with known allergy to rocuronium or cis-atracurium&#xD;
  &#xD;
            -  patients in whom it is impossible to measure the depth of the neuromuscular block on&#xD;
               the upper extremities (injuries of the upper extremities, contractures etc.)&#xD;
  &#xD;
            -  patients undergoing surgery positioned on their side&#xD;
  &#xD;
            -  patients with an upper arm injury&#xD;
  &#xD;
            -  patients with acromegaly&#xD;
  &#xD;
            -  patients with Alzheimer's disease&#xD;
  &#xD;
            -  patients with the risk of difficult airways&#xD;
  &#xD;
            -  patients induced into general anaesthesia via the Rapid Sequence Induction method&#xD;
  &#xD;
            -  patients with a weight under 5 kilograms&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michal Kalina, MUDr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michal Kalina, MUDr.</last_name>
      <phone>+420477112202</phone>
      <phone_ext>+420</phone_ext>
      <email>michal.kalina@kzcr.eu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.</name>
        <address>
          <city>Ústí Nad Labem</city>
          <state>Ústí Nad Labem Region</state>
          <zip>40001</zip>
          <country>Czechia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.</investigator_affiliation>
      <investigator_full_name>Michal Kalina</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <keyword>neuromuscular blockade</keyword>
    <keyword>electromyography</keyword>
    <keyword>kine-myography</keyword>
    <keyword>general anaesthesia</keyword>
    <keyword>rocuronium</keyword>
    <keyword>cis-atracurium</keyword>
    <keyword>residual neuromuscular blockade</keyword>
    <keyword>sugammadex</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992090
  org study id: EMG vs KMG
  nct id: NCT05992090
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography
        and Electromyography.
  
        The main questions to answer are:
  
          -  are electromyography and kine-myography interchangeable
  
          -  is electromyography linked to fewer fault results
  
          -  is electromyography using lower energy to stimulate nerves
  
        The type of study is a multicentric observational clinical trial. Subjects are patients
        undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient,
        the neuromuscular blockade will be monitored using kine-myograph and electromyography
        simultaneously.
  Informed consent will first be obtained from the patient for inclusion in the study. Consent
        will be obtained during an examination by the anaesthesiologist providing anaesthetic care
        during surgery in the anteroom of the operating theatre.
  
        Once informed consent has been obtained, a routine orientation examination will be performed
        by the anaesthetist and routine pre-operative preparation (provision of peripheral venous
        access, risk assessment for airway obstruction, etc.) will be performed. The patient will
        then be transported to the operating theatre.
  
        In the operating room, patient monitoring will be initiated, including the deployment of
        sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the
        right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb
        fixation will be performed by the anaesthetic nurse. The fixation will be performed with
        splints compatible with the operating table. Fixation of the limbs and sensor with adhesive
        tape will not be used.
  
        The anaesthesia will then be induced. Propofol and sufentanil will be administered at the
        discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation
        has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade
        will be performed. After calibration of the sensors, the supramaximal current to the CRF will
        be recorded. The measurement interval will be set to 20 s. After securing the airway, the
        interval will be extended to 5 - 15 min according to the nature of the surgery and the
        discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT)
        and the Train Of Four (TOF) value will be recorded throughout the procedure.
  
        On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once
        sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring
        of the depth of neuromuscular blockade will be discontinued.
  
        If during the measurement of the depth of neuromuscular blockade a value is measured that is
        highly suspected to be in error, this suspicion will be recorded in the CRF with a
        justification.
  observational model: Cohort
  time perspective: Prospective
  measure: Measurement variability
  time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
  description: A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.
  measure: supramaximal electric stimulus
  time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
  description: A secondary aim is to demonstrate that measuring the depth of neuromuscular blockade using kinemyography is associated with a higher supramaximal electric stimulus than measuring the depth of neuromuscular blockade using electromyography.
  measure: TOF overestimation
  time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
  description: The primary objective of the study is to demonstrate that there is measured higher TOF when using KMG to monitor the depth of neuromuscular blockade compared to using EMG sensor to monitor the depth of neuromuscular blockade.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Michal Kalina, MUDr.
  role: Principal Investigator
  affiliation: Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL
  last name: Michal Kalina, MUDr.
  phone: +420477112202
  phone ext: +420
  email: michal.kalina@kzcr.eu
  facility: 
  country: Czechia
  responsible party type: Principal Investigator
  investigator affiliation: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
  investigator full name: Michal Kalina
  investigator title: principal investigator
  mesh term: Delayed Emergence from Anesthesia
  sharing ipd: Undecided