<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/NCT04459533</url>
  </required_header>
  <id_info>
    <org_study_id>2020_TOF-COVID</org_study_id>
    <nct_id>NCT04459533</nct_id>
  </id_info>
  <brief_title>Sparing in Neuromuscular Blockade in COVID 19 ICU</brief_title>
  <acronym>TOF-COVID</acronym>
  <official_title>The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective case-controlled study of the effect of the use of a neuromuscular&#xD;
      blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical&#xD;
      ventilation in the context of COVID-19.&#xD;
&#xD;
      The use of NMB agents during mechanical ventilation in patients with acute respiratory&#xD;
      distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In&#xD;
      the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in&#xD;
      intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of&#xD;
      NMB agents. Large amount of such patient admitted in a short time has led to a shortage of&#xD;
      NMB agents, particularly cisatracurium.&#xD;
&#xD;
      The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in&#xD;
      general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients&#xD;
      available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB&#xD;
      monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of&#xD;
      Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.&#xD;
&#xD;
      The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of&#xD;
      NMB agents in patients under mechanical ventilation in the context of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NMB agents consumption</measure>
    <time_frame>ICU discharge an average of 4 weeks</time_frame>
    <description>We measured the total NMB agents consumption during the stay: cisatracurium and/or atracurium (milligram). Nurses report continuous infusion rates of NMB agents. By extracting this data we were able to retrieve the total approximate dose (we're missing the bolus doses).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <condition>Human Characteristics</condition>
  <condition>Complication of Medical Care</condition>
  <condition>Intensive Care Unit Acquired Weakness</condition>
  <arm_group>
    <arm_group_label>TOF group</arm_group_label>
    <description>COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, for whom a NMB monitor use (TOF) was reported in the electronic health records (EHR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, with no NMB monitor use reported in the EHR</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TOF protocol</intervention_name>
    <description>To the introduction of CISATRACURIUM, Initial bolus was at 0.2mg/kg and initial continuous infusion at 0.18mg/kg/h of theoretical ideal weight.&#xD;
To the introduction of ATRACURIUM, initial bolus was at 0.5mg/kg and initial continuous infusion at 0.5mg/kg/h of theoretical ideal weight.&#xD;
Introduction of NMBA was associated to deep sedation (RASS - 4 or RAMSAY 6; BIS 40 to 60).&#xD;
TOF was measured through the electric stimulation of peripheral nerves (facial or ulnar nerve).&#xD;
The dose of NMB agents was then adapted according to the number of answers to the TOF, per 4 hours:&#xD;
If 0 response and no respiratory asynchrony: no change in flow rate&#xD;
If &gt;=1 or respiratory asynchrony: increase of the continuous curare flow by 20% preceded by a bolus identical to the one administered at the beginning of NMB agent, then recheck at H+1.</description>
    <arm_group_label>TOF group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We included all COVID patients in ICU university hospitals in Lyon who required mechanical&#xD;
        ventilation and NMB for at least 48 hours.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCR-proven SARS-CoV-2 infection&#xD;
&#xD;
          -  Use of VM (mechanical ventilation)&#xD;
&#xD;
          -  Use of NMB agents for at least 48 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  extracorporeal membrane oxygenation (ECMO)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neuromuscular blockade agent</keyword>
  <keyword>neuromuscular blockade monitor</keyword>
  <keyword>Train of Four (TOF)</keyword>
  <keyword>critical illness</keyword>
  <keyword>COVID 19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <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/NCT04459533
org study id: 2020_TOF-COVID
nct id: NCT04459533
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a retrospective case-controlled study of the effect of the use of a neuromuscular
      blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical
      ventilation in the context of COVID-19.

      The use of NMB agents during mechanical ventilation in patients with acute respiratory
      distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In
      the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in
      intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of
      NMB agents. Large amount of such patient admitted in a short time has led to a shortage of
      NMB agents, particularly cisatracurium.

      The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in
      general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients
      available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB
      monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of
      Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.

      The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of
      NMB agents in patients under mechanical ventilation in the context of COVID-19.
observational model: Case-Control
time perspective: Retrospective
measure: NMB agents consumption
time frame: ICU discharge an average of 4 weeks
description: We measured the total NMB agents consumption during the stay: cisatracurium and/or atracurium (milligram). Nurses report continuous infusion rates of NMB agents. By extracting this data we were able to retrieve the total approximate dose (we're missing the bolus doses).
arm group label: TOF group
description: COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, for whom a NMB monitor use (TOF) was reported in the electronic health records (EHR).
arm group label: Control group
description: COVID-19 patients admitted to the ICU, receiving mechanical ventilation and NMB agents, with no NMB monitor use reported in the EHR
intervention type: Device
intervention name: TOF protocol
description: To the introduction of CISATRACURIUM, Initial bolus was at 0.2mg/kg and initial continuous infusion at 0.18mg/kg/h of theoretical ideal weight.
To the introduction of ATRACURIUM, initial bolus was at 0.5mg/kg and initial continuous infusion at 0.5mg/kg/h of theoretical ideal weight.
Introduction of NMBA was associated to deep sedation (RASS - 4 or RAMSAY 6; BIS 40 to 60).
TOF was measured through the electric stimulation of peripheral nerves (facial or ulnar nerve).
The dose of NMB agents was then adapted according to the number of answers to the TOF, per 4 hours:
If 0 response and no respiratory asynchrony: no change in flow rate
If >=1 or respiratory asynchrony: increase of the continuous curare flow by 20% preceded by a bolus identical to the one administered at the beginning of NMB agent, then recheck at H+1.
arm group label: TOF group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No