xml: <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/NCT05975411</url>
    </required_header>
    <id_info>
      <org_study_id>18-180</org_study_id>
      <nct_id>NCT05975411</nct_id>
    </id_info>
    <brief_title>Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.</brief_title>
    <acronym>CATmedO</acronym>
    <official_title>Telemedicine Anesthesia Consultation, Pilot Study in Obstetrics.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</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>
        Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a&#xD;
        pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the&#xD;
        maternity hospital of the CHU will be invited to carry out their anesthesia consultation with&#xD;
        a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way&#xD;
        of the telemedicine trolley installed in a center close to their place of residence, or at&#xD;
        the CHU de Caen as usual.&#xD;
  &#xD;
        The validation of the adequacy of the possibilities of telemedicine with the requirements of&#xD;
        the anesthesia consultation worked upstream is the main objective of this work, the&#xD;
        appreciation of the parturient at this consultation, the appreciation of the consulting and&#xD;
        validating professionals will also be collected with the aim of a maximum optimization of&#xD;
        this new offer intended for the region.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 11, 2021</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Actual">March 15, 2021</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>assessment of the airways via a telemedicine device</measure>
      <time_frame>baseline</time_frame>
      <description>Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are:&#xD;
  Mouth opening&#xD;
  Mallampati score&#xD;
  Cervical spine mobility&#xD;
  Thyro-chin distance&#xD;
  Patient Profile&#xD;
  Lip test</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>telemedecine cabin</arm_group_label>
      <description>Anesthesia Consultation with telemedicine cabin installed in Dozulé</description>
    </arm_group>
    <arm_group>
      <arm_group_label>telemedicine trolley</arm_group_label>
      <description>Anesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence</description>
    </arm_group>
    <arm_group>
      <arm_group_label>standard</arm_group_label>
      <description>Anesthesia Consultation at the CHU de Caen as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Anesthesia Consultation with telemedicine</intervention_name>
      <description>Anesthesia Consultation with telemedicine</description>
      <arm_group_label>telemedecine cabin</arm_group_label>
      <arm_group_label>telemedicine trolley</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          pregnancy women&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant woman&#xD;
  &#xD;
            -  over 18 years old&#xD;
  &#xD;
            -  beneficiary of social security/CMU&#xD;
  &#xD;
            -  Non-emergency pre-anesthesia consultation&#xD;
  &#xD;
            -  delivery planned at the maternity ward of the University Hospital of Caen&#xD;
  &#xD;
            -  living in the vicinity of Dozulé or living near an establishment with a telemedicine&#xD;
               cart equipped with the necessary equipment&#xD;
  &#xD;
            -  Having received clear and honest information about the study, and having given their&#xD;
               consent&#xD;
  &#xD;
            -  Having given their consent for a telemedicine consultation&#xD;
  &#xD;
            -  patient without comorbidity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  Patient under guardianship&#xD;
  &#xD;
            -  Patient with psychomotor disability; hearing impaired; visually impaired&#xD;
  &#xD;
            -  Difficulties in understanding information, expression; foreign language&#xD;
  &#xD;
            -  Pathological pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>pregnancy</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>CAEN University Hospital</name>
        <address>
          <city>Caen</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975411
  org study id: 18-180
  nct id: NCT05975411
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pilot study in Lower Normandy concerning a total of 90 patients scheduled for a
        pre-anaesthesia consultation in obstetrics. These parturients who plan to give birth at the
        maternity hospital of the CHU will be invited to carry out their anesthesia consultation with
        a view to childbirth either by way of the telemedicine cabin installed in Dozulé, or by way
        of the telemedicine trolley installed in a center close to their place of residence, or at
        the CHU de Caen as usual.
  
        The validation of the adequacy of the possibilities of telemedicine with the requirements of
        the anesthesia consultation worked upstream is the main objective of this work, the
        appreciation of the parturient at this consultation, the appreciation of the consulting and
        validating professionals will also be collected with the aim of a maximum optimization of
        this new offer intended for the region.
  observational model: Cohort
  time perspective: Prospective
  measure: assessment of the airways via a telemedicine device
  time frame: baseline
  description: Composite score (rated from 5 to 14) evaluating the risk of difficult orotracheal intubation which is based on the five main elements of the airway evaluation during the anesthesia consultation which are:
  Mouth opening
  Mallampati score
  Cervical spine mobility
  Thyro-chin distance
  Patient Profile
  Lip test
  arm group label: telemedecine cabin
  description: Anesthesia Consultation with telemedicine cabin installed in Dozulé
  arm group label: telemedicine trolley
  description: Anesthesia Consultation with telemedicine by way of the telemedicine trolley installed in a center close to their place of residence
  arm group label: standard
  description: Anesthesia Consultation at the CHU de Caen as usual.
  intervention type: Other
  intervention name: Anesthesia Consultation with telemedicine
  description: Anesthesia Consultation with telemedicine
  arm group label: telemedecine cabin
  arm group label: telemedicine trolley
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: pregnancy
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Anesthetics
  sharing ipd: No