<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/NCT03291184</url>
  </required_header>
  <id_info>
    <org_study_id>EN_GC_2017</org_study_id>
    <nct_id>NCT03291184</nct_id>
  </id_info>
  <brief_title>Postoperative Residual Paralysis After Cardiac Surgery</brief_title>
  <official_title>Is Postoperative Residual Curarisation Still an Issue at the Moment of Weaning of the ICU Patient Following Cardiac Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      The main objective of this study is to describe the incidence of postoperative residual&#xD;
      paralysis (mean train-of-four &lt;90%) when weaning from the ventilator in patients admitted to&#xD;
      the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a&#xD;
      widely used term for the peripheral nerve stimulation used in neuromuscular blockade&#xD;
      monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will&#xD;
      perform a measurement of the train-of-four at the thumb with a neuromuscular transmission&#xD;
      monitor. Every value below 90% will be considered as residual paralysis and treated&#xD;
      appropriately by means of a reversal agent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven&#xD;
      institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is&#xD;
      normothermic, hemodynamically stable, has normal blood gasses and absence of residual&#xD;
      bleeding. The ICU nurse caring for the patient will start weaning the patient from the&#xD;
      ventilator, following these departmental guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">March 8, 2018</completion_date>
  <primary_completion_date type="Actual">January 2, 2018</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>
    <intervention_model_description>Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The participant will still be under sedation at the moment of measuring neuromuscular blockade. The care provider will perform measurements, while the investigator is blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative residual curarisation</measure>
    <time_frame>6 hours after arrival in the ICU</time_frame>
    <description>mean train-of-four &lt;90% as measured by neuromuscular blockade monitoring</description>
  </primary_outcome>
  <enrollment type="Actual">93</enrollment>
  <condition>Postoperative Residual Curarization</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>peripheral neuromuscular monitor</intervention_name>
    <description>Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted to the ICU after elective cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency cardiac surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GUY CAMMU</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>Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14.</citation>
    <PMID>17486918</PMID>
  </reference>
  <reference>
    <citation>Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24.</citation>
    <PMID>21865491</PMID>
  </reference>
  <reference>
    <citation>Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. doi: 10.1177/106002809603000211.</citation>
    <PMID>8835051</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>April 9, 2018</last_update_submitted>
  <last_update_submitted_qc>April 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2018</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>MD, PhD, Staff Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>neuromuscular blockade</keyword>
  <keyword>neuromuscular monitoring</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>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/NCT03291184
org study id: EN_GC_2017
nct id: NCT03291184
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to describe the incidence of postoperative residual
      paralysis (mean train-of-four <90%) when weaning from the ventilator in patients admitted to
      the Intensive Care Unit (ICU) after elective cardiac surgery. Train-of-four monitoring is a
      widely used term for the peripheral nerve stimulation used in neuromuscular blockade
      monitoring. When the patient is ready for weaning from the ventilator, an ICU doctor will
      perform a measurement of the train-of-four at the thumb with a neuromuscular transmission
      monitor. Every value below 90% will be considered as residual paralysis and treated
      appropriately by means of a reversal agent.
Postoperatively, in the ICU, readiness-for-weaning is based on ICU doctor-nurse-driven
      institutional weaning guidelines: 6 hours after arrival in the ICU, a patient who is
      normothermic, hemodynamically stable, has normal blood gasses and absence of residual
      bleeding. The ICU nurse caring for the patient will start weaning the patient from the
      ventilator, following these departmental guidelines.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients admitted to the ICU after elective cardiac surgery and ready for weaning from the ventilator.
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
masking description: The participant will still be under sedation at the moment of measuring neuromuscular blockade. The care provider will perform measurements, while the investigator is blinded.
measure: postoperative residual curarisation
time frame: 6 hours after arrival in the ICU
description: mean train-of-four <90% as measured by neuromuscular blockade monitoring
intervention type: Device
intervention name: peripheral neuromuscular monitor
description: Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: GUY CAMMU
role: Principal Investigator
affiliation: Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium
facility: 
country: Belgium
citation: Cammu G. How rational is muscle relaxation during cardiac surgery? Acta Anaesthesiol Belg. 2007;58(1):7-14.
PMID: 17486918
citation: Videira RL, Vieira JE. What rules of thumb do clinicians use to decide whether to antagonize nondepolarizing neuromuscular blocking drugs? Anesth Analg. 2011 Nov;113(5):1192-6. doi: 10.1213/ANE.0b013e31822c986e. Epub 2011 Aug 24.
PMID: 21865491
citation: Rudis MI, Guslits BG, Zarowitz BJ. Technical and interpretive problems of peripheral nerve stimulation in monitoring neuromuscular blockade in the intensive care unit. Ann Pharmacother. 1996 Feb;30(2):165-72. doi: 10.1177/106002809603000211.
PMID: 8835051
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouw Hospital
investigator full name: Guy CAMMU
investigator title: MD, PhD, Staff Anesthesiologist
mesh term: Delayed Emergence from Anesthesia
sharing ipd: No