<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/NCT02239965</url>
  </required_header>
  <id_info>
    <org_study_id>JLT-NM3</org_study_id>
    <nct_id>NCT02239965</nct_id>
  </id_info>
  <brief_title>Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia</brief_title>
  <official_title>Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <brief_summary>
    <textblock>
      Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications&#xD;
      and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia&#xD;
      personnel. Surveys show that part of the explanation is that the anaesthetists often&#xD;
      experience problems with the equipment used for monitoring, though the problems have not been&#xD;
      described in detail.&#xD;
&#xD;
      We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by&#xD;
      insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in&#xD;
      interpreting the measurement results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the barriers to consistent neuromuscular monitoring, based on a qualitative analysis of focus group interviews with anaesthesiologists and nurse anaesthetists</measure>
    <time_frame>Focus group interviews conducted Sep. - Oct. 2014 (2 months)</time_frame>
    <description>Focus group interviews will collect participants' perspectives and will be analyzed for thoughts, opinions, and feelings in regard to neuromuscular monitoring. Specific problems experienced with the equipment and other possible barriers to the consistent use of monitoring will be described qualitatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the problems experienced with neuromuscular monitoring in daily clinical practice</measure>
    <time_frame>Clinical observations conducted in Sep. - Oct. 2014 (2 months)</time_frame>
    <description>The problems experienced with neuromuscular monitoring will be described through a qualitative analysis of clinical observations of the personnel's daily use of the monitoring equipment,</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Neuromuscular Blockade</condition>
  <arm_group>
    <arm_group_label>Anaesthesia personnel</arm_group_label>
    <description>Anaesthesiologists and nurse anaesthetists</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Anaesthesiologists and nurse anaesthetists at Danish anaesthesia departments.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  has been working in the field of anaesthesiology for at least 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#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>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Jakob Louis Thomsen</investigator_full_name>
    <investigator_title>MD, PhD student</investigator_title>
  </responsible_party>
  <keyword>Neuromuscular blockade</keyword>
  <keyword>Neuromuscular monitoring</keyword>
  <keyword>Focus group interview</keyword>
  <keyword>Clinical observation</keyword>
  <!-- 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/NCT02239965
org study id: JLT-NM3
nct id: NCT02239965
lead sponsor: 
Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications
      and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia
      personnel. Surveys show that part of the explanation is that the anaesthetists often
      experience problems with the equipment used for monitoring, though the problems have not been
      described in detail.

      We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by
      insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in
      interpreting the measurement results.
observational model: Case-Only
time perspective: Prospective
measure: Description of the barriers to consistent neuromuscular monitoring, based on a qualitative analysis of focus group interviews with anaesthesiologists and nurse anaesthetists
time frame: Focus group interviews conducted Sep. - Oct. 2014 (2 months)
description: Focus group interviews will collect participants' perspectives and will be analyzed for thoughts, opinions, and feelings in regard to neuromuscular monitoring. Specific problems experienced with the equipment and other possible barriers to the consistent use of monitoring will be described qualitatively.
measure: Description of the problems experienced with neuromuscular monitoring in daily clinical practice
time frame: Clinical observations conducted in Sep. - Oct. 2014 (2 months)
description: The problems experienced with neuromuscular monitoring will be described through a qualitative analysis of clinical observations of the personnel's daily use of the monitoring equipment,
arm group label: Anaesthesia personnel
description: Anaesthesiologists and nurse anaesthetists
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Jakob Louis Thomsen
investigator title: MD, PhD student