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/NCT05964075</url>
    </required_header>
    <id_info>
      <org_study_id>RASECAL Study</org_study_id>
      <nct_id>NCT05964075</nct_id>
    </id_info>
    <brief_title>RASECAL-Bronchoscopic Ambusampler</brief_title>
    <acronym>Rasecal</acronym>
    <official_title>A Randomized Controlled Trial to Assess the Safety and Efficiency of a Self-Contained Sampling Device /Disposable Bronchoscope System Versus Usual sampLing Procedure.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chelsea and Westminster NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chelsea and Westminster NHS Foundation Trust</source>
    <brief_summary>
      <textblock>
        Prospective, multi-centre, open labelled, 1:1randomized controlled study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Patients admitted to ICU with acute respiratory failure, requiring mechanical&#xD;
             ventilation with, suspected or confirmed COVID-19.&#xD;
  &#xD;
          2. Patients admitted to ICU with acute respiratory failure due to a condition other than&#xD;
             COVID-19, requiring mechanical ventilation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 14, 2022</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Comparison of two sampling pots</measure>
      <time_frame>1month</time_frame>
      <description>Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?</description>
    </primary_outcome>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Respiratory Failure</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients requiring clinical bronchoscopy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (All are required)&#xD;
  &#xD;
            -  Clinicians experienced in performing bronchoscopies (i.e. bronchoscopists should have&#xD;
               performed a minimum 5 bronchoscopies in mechanically ventilated patients and a minimum&#xD;
               of 5 bronchoscopies in a simulated or practice setting).&#xD;
  &#xD;
            -  Clinicians who have undergone the online product-training module for the use of the&#xD;
               Ambu Bronchosampler, with self-certification documented.&#xD;
  &#xD;
            -  Clinicians who have simulated the online product training module using an Ambu&#xD;
               Bronchosampler and Ambu Ascope4 a minimum of 5 times in a practice setting and have&#xD;
               self-certified.&#xD;
  &#xD;
          Population&#xD;
  &#xD;
            -  Patients ≥ 18 years old&#xD;
  &#xD;
            -  Patients on mechanical ventilation with Acute respiratory failure for &gt;4h&#xD;
  &#xD;
            -  Patients eligible for a clinically indicated bronchoscopy with fluid sampling. Patient&#xD;
               information has been explained and verbal or written consent has been obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Investigators&#xD;
  &#xD;
            -  Investigators who have not completed product training in aScope BronchoSampler by&#xD;
               online and hands-on from Ambu product specialists or an experienced user from the&#xD;
               site.&#xD;
  &#xD;
            -  Investigators with experience in &lt; 5 self-verified simulated fluid sampling procedures&#xD;
               using the Ambu BronchoSampler 4.8.2 Population&#xD;
  &#xD;
            -  Clinician concern regarding safety of bronchoscopy&#xD;
  &#xD;
            -  Involved study personal not available to perform the procedure and enroll the patient&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Damon 0 Foster, 0</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chelsea and Westminster NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Arnold Xhikola</last_name>
      <phone>203356825</phone>
      <email>arnold.xhikola1@nhs.net</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chelsea and Westminster Hospital NHSFT</name>
        <address>
          <city>London</city>
          <zip>SW10 0XD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Arnold 0 Xhikola</last_name>
        <phone>0203356825</phone>
        <email>chelwest.rasecal@nhs.net</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <!-- 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/NCT05964075
  org study id: RASECAL Study
  nct id: NCT05964075
  lead sponsor: 
  Prospective, multi-centre, open labelled, 1:1randomized controlled study.
  1. Patients admitted to ICU with acute respiratory failure, requiring mechanical
             ventilation with, suspected or confirmed COVID-19.
  
          2. Patients admitted to ICU with acute respiratory failure due to a condition other than
             COVID-19, requiring mechanical ventilation.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparison of two sampling pots
  time frame: 1month
  description: Can the Ambu Bronchosampler improve safety versus usual standard care by reducing the risk of spillage or disconnection of the sampling system during a procedure?
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  last name: Damon 0 Foster, 0
  role: Principal Investigator
  affiliation: Chelsea and Westminster NHS Foundation Trust
  last name: Arnold Xhikola
  phone: 203356825
  email: arnold.xhikola1@nhs.net
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency