<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/NCT03232840</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0228</org_study_id>
    <nct_id>NCT03232840</nct_id>
  </id_info>
  <brief_title>E-learning to Prevent Wrong Site Surgery in Anesthesia</brief_title>
  <acronym>ELPSite</acronym>
  <official_title>Evaluation of an E-learning to Prevent Wrong Site Surgery in Anesthesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 purpose of this observational study is to assess the efficiency of an e-learning in order&#xD;
      to put into practice some preventive measures to avoid wrong site surgery during anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before the study, the investigators selected 7 preventive measures to avoid wrong site&#xD;
      surgery during regional anesthesia combined or not with general anesthesia . These measures&#xD;
      were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during&#xD;
      conventional meetings. An initial evaluation of the application of these measures will be&#xD;
      carried out before the introduction of e-learning. This assessment will be conducted by&#xD;
      nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation,&#xD;
      e-learning will be broadcast on the hospital intranet. Then a second evaluation of the&#xD;
      application of the preventive measures will be carried out 6 month and 1 year after the&#xD;
      introduction of e-learning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure. This questionnaire simply indicates whether a measure has been applied or not</description>
  </primary_outcome>
  <other_outcome>
    <measure>Assessment of the application of each of the 7 preventive measures according to various clinical parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of the application of each of the 7 preventive measures according to the clinical parameters of the patients followed (age of the patient, ASA physical status, type of surgery, type of anesthesia, period of the day or week, Emergency or elective).</description>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.</measure>
    <time_frame>6 month and 1 year</time_frame>
    <description>Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.</description>
  </other_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Medical Errors : Wrong Site Surgery in Regional Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing anesthesia in Lapeyronie Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patient undergoing regional anesthesia with or without general anesthesia&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  general anesthesia without regional anesthesia&#xD;
&#xD;
          -  perimedullar anesthesia&#xD;
&#xD;
          -  bilateral surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BIBOULET Philippe, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wrong site surgery in regional anesthesia</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03232840
org study id: RECHMPL17_0228
nct id: NCT03232840
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to assess the efficiency of an e-learning in order
      to put into practice some preventive measures to avoid wrong site surgery during anesthesia.
Before the study, the investigators selected 7 preventive measures to avoid wrong site
      surgery during regional anesthesia combined or not with general anesthesia . These measures
      were learned to the entire anesthesia team (nurse, resident and anesthesiologist) during
      conventional meetings. An initial evaluation of the application of these measures will be
      carried out before the introduction of e-learning. This assessment will be conducted by
      nurses without the knowledge of the anesthetic team evaluated. After this initial evaluation,
      e-learning will be broadcast on the hospital intranet. Then a second evaluation of the
      application of the preventive measures will be carried out 6 month and 1 year after the
      introduction of e-learning.
observational model: Other
time perspective: Prospective
measure: Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure
time frame: 1 day
description: Evaluation of the application of each of the 7 preventive measures using a questionnaire filled by a nurse not involved in the regional anesthesia procedure. This questionnaire simply indicates whether a measure has been applied or not
measure: Assessment of the application of each of the 7 preventive measures according to various clinical parameters
time frame: 1 day
description: Evaluation of the application of each of the 7 preventive measures according to the clinical parameters of the patients followed (age of the patient, ASA physical status, type of surgery, type of anesthesia, period of the day or week, Emergency or elective).
measure: Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
time frame: 6 month and 1 year
description: Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: BIBOULET Philippe, MD, PhD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC