<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/NCT03804346</url>
  </required_header>
  <id_info>
    <org_study_id>17-449-101</org_study_id>
    <nct_id>NCT03804346</nct_id>
  </id_info>
  <brief_title>Infantile - Postoperative Residual Curarization - Study</brief_title>
  <acronym>I-PORC</acronym>
  <official_title>Observational Study to Detect Postoperative Residual Curarization in Infantile Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Regensburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Regensburg</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>
      The primary object of this study is, to investigate the current procedure of neuromuscular&#xD;
      monitoring at a tertiary academic university medical center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual neuromuscular block is known to be a significant but frequently overlooked&#xD;
      complication after the use of neuromuscular blocking agents. Aim of this prospective,&#xD;
      observational study is to detect the incidence and severity of residual paralysis at a&#xD;
      tertiary academic german university medical center.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      All infantile patients recieving neuromuscular blocking agents are included over a 12 week&#xD;
      observational period. At the end of the operation procedure, directly prior to tracheal&#xD;
      extubation a train-of-four ratio was assessed quantitatively by an independet observer using&#xD;
      the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the&#xD;
      operating theatre, during the way to the postoperative care unit (PACU) and during the stay&#xD;
      in the PACU:&#xD;
&#xD;
        -  incidence of residual paralysis&#xD;
&#xD;
        -  incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway&#xD;
           obstruction,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">July 23, 2017</completion_date>
  <primary_completion_date type="Actual">July 23, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Residual paralysis</measure>
    <time_frame>Directly prior to extubation</time_frame>
    <description>Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Airway obstruction</measure>
    <time_frame>1, 10, 30, 60 minutes after extubation</time_frame>
    <description>Clinical assessment of the upper airway</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen desaturation</measure>
    <time_frame>1, 10, 30, 60 minutes after extubation</time_frame>
    <description>Measurement of the oxygen saturation by pulse oxymetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchospasm, laryngospasm</measure>
    <time_frame>1, 10, 30, 60 minutes after extubation</time_frame>
    <description>Clinical assessment the airway</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Postoperative Residual Curarization</condition>
  <condition>Neuromuscular Blockade</condition>
  <condition>Neuromuscular Monitoring</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Acceleromyography</intervention_name>
    <description>At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with&#xD;
        muscle relaxation due to surgical or diagnostical procedures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General aneasthesia with muscle relaxation&#xD;
&#xD;
          -  Children between 1 Month to 18 Years&#xD;
&#xD;
          -  Endotracheal Intubation due to surgical or diagnostical procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  older than 18 years&#xD;
&#xD;
          -  local aneasthesia&#xD;
&#xD;
          -  regional aneasthesia&#xD;
&#xD;
          -  larynx mask&#xD;
&#xD;
          -  patient comes from ICU&#xD;
&#xD;
          -  children who are not planned to be extubated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Unterbuchner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University medical center Regensburg, Department of anaesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Regensburg</name>
      <address>
        <city>Regensburg</city>
        <state>Bavaria</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Regensburg</investigator_affiliation>
    <investigator_full_name>Christoph Unterbuchner</investigator_full_name>
    <investigator_title>Principal Investigator, Dr. med. Christoph Unterbuchner, Staff Anaesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Emergence from Anesthesia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03804346
org study id: 17-449-101
nct id: NCT03804346
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary object of this study is, to investigate the current procedure of neuromuscular
      monitoring at a tertiary academic university medical center.
Residual neuromuscular block is known to be a significant but frequently overlooked
      complication after the use of neuromuscular blocking agents. Aim of this prospective,
      observational study is to detect the incidence and severity of residual paralysis at a
      tertiary academic german university medical center.

      Methods:

      All infantile patients recieving neuromuscular blocking agents are included over a 12 week
      observational period. At the end of the operation procedure, directly prior to tracheal
      extubation a train-of-four ratio was assessed quantitatively by an independet observer using
      the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the
      operating theatre, during the way to the postoperative care unit (PACU) and during the stay
      in the PACU:

        -  incidence of residual paralysis

        -  incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway
           obstruction,
observational model: Cohort
time perspective: Prospective
measure: Residual paralysis
time frame: Directly prior to extubation
description: Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.
measure: Airway obstruction
time frame: 1, 10, 30, 60 minutes after extubation
description: Clinical assessment of the upper airway
measure: Oxygen desaturation
time frame: 1, 10, 30, 60 minutes after extubation
description: Measurement of the oxygen saturation by pulse oxymetry
measure: Bronchospasm, laryngospasm
time frame: 1, 10, 30, 60 minutes after extubation
description: Clinical assessment the airway
intervention type: Diagnostic Test
intervention name: Acceleromyography
description: At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoph Unterbuchner, MD
role: Principal Investigator
affiliation: University medical center Regensburg, Department of anaesthesiology
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Regensburg
investigator full name: Christoph Unterbuchner
investigator title: Principal Investigator, Dr. med. Christoph Unterbuchner, Staff Anaesthesiologist
mesh term: Delayed Emergence from Anesthesia