<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/NCT04479007</url>
  </required_header>
  <id_info>
    <org_study_id>NL61112.018.17</org_study_id>
    <nct_id>NCT04479007</nct_id>
  </id_info>
  <brief_title>CLE and OCT in Acute Respiratory Insufficiency</brief_title>
  <acronym>CLEOPATRA</acronym>
  <official_title>Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Acute respiratory distress syndrome is a severe complication of critical illness. The&#xD;
      diagnosis of ARDS is difficult, and it could be important to differentiate ARDS from other&#xD;
      causes of acute respiratory failure. Innovative probe-based imaging techniques such as&#xD;
      'Confocal Laser Endomicroscopy' (CLE) and Optical Coherence Tomography (OCT) are high&#xD;
      resolution optical techniques that, combined with conventional bronchoscopy, have been found&#xD;
      to provide non-invasive, real-time near-histology information about the alveolar compartment&#xD;
      in non ventilated non-critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is important to identify the underlying cause of respiratory failure, in order to&#xD;
      determine the appropriate treatment. Histopathology would help treatment decisions, however&#xD;
      is in the fast majority of this critically ill patient-group not available. CLE is enables&#xD;
      near histology/microscopic analysis during bronchoscopy, by tissue illumination with a&#xD;
      low-power laser. Optical Coherence Tomography is the optical equivalent of B-mode&#xD;
      ultrasonography, that consists of a small rotating optical fibre. Both the CLE and OCT&#xD;
      techniques are minimally invasive and little time consuming. Therefore different areas of the&#xD;
      lung can be sequentially imaged. With this pilot study the investigators aim to describe&#xD;
      normal alveolar areas and areas with abnormalities in critically ill patients with non&#xD;
      resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or&#xD;
      without bronchoalveolar lavage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">August 11, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 11, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients</measure>
    <time_frame>coss sectional (1 day)</time_frame>
    <description>Percentage of successful imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of pCLE/OCT to radiological patterns</measure>
    <time_frame>cross sectional (1 day)</time_frame>
    <description>Degree of similarity pCLE/OCT-imaging compared to HRCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of pCLE/OCT with pathology</measure>
    <time_frame>cross sectional (1 day)</time_frame>
    <description>Degree of similarity between pCLE/OCT characteristics with pathology (in case available)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Respiratory Failure (Non Resolving)</condition>
  <arm_group>
    <arm_group_label>Mechanically ventilated patients</arm_group_label>
    <description>Critically ill patients of 18 years or older who receive invasive mechanical ventilation for acute respiratory failure and have an indication for an intervention in the airways.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Probe based optical techniques</intervention_name>
    <description>During the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT).</description>
    <arm_group_label>Mechanically ventilated patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mechanically ventilated patients mandating a procedure that includes inspection of the&#xD;
        airways and can be combined with pCLE/OCT. Patients can only be included when the research&#xD;
        physician decides they are eligible. (based on the heterogeneity of the disease and the&#xD;
        suspected etiology).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to intensive care unit of academic medical center in Amsterdam&#xD;
&#xD;
          -  Indication for a procedure to investigate the airways that can be combined with&#xD;
             pCLE/OCT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability and willingness to provide informed consent by family-members&#xD;
&#xD;
          -  Inability to comply with the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jouke T Annema, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcus J Schultz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kirsten Kalverda, MD</last_name>
    <phone>+31205664356</phone>
    <email>k.a.kalverda@amsterdamumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lizzy Wijmans, MD</last_name>
    <email>l.wijmans@amsterdamumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kirsten Kalverda, MD</last_name>
      <phone>+31205664356</phone>
      <email>k.a.kalverda@amsterdamumc.nl</email>
    </contact>
    <investigator>
      <last_name>Jouke T Annema, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lizzy Wijmans, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marcus J Schultz, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lieuwe Bos, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter I Bonta, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kirsten Kalverda, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>October 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof J.T. Annema</investigator_full_name>
    <investigator_title>Head of department of pulmonal endoscopy</investigator_title>
  </responsible_party>
  <keyword>Confocal Laser Endomicroscopy</keyword>
  <keyword>Optical coherence Tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We plan to share the data.</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/NCT04479007
org study id: NL61112.018.17
nct id: NCT04479007
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute respiratory distress syndrome is a severe complication of critical illness. The
      diagnosis of ARDS is difficult, and it could be important to differentiate ARDS from other
      causes of acute respiratory failure. Innovative probe-based imaging techniques such as
      'Confocal Laser Endomicroscopy' (CLE) and Optical Coherence Tomography (OCT) are high
      resolution optical techniques that, combined with conventional bronchoscopy, have been found
      to provide non-invasive, real-time near-histology information about the alveolar compartment
      in non ventilated non-critically ill patients.
It is important to identify the underlying cause of respiratory failure, in order to
      determine the appropriate treatment. Histopathology would help treatment decisions, however
      is in the fast majority of this critically ill patient-group not available. CLE is enables
      near histology/microscopic analysis during bronchoscopy, by tissue illumination with a
      low-power laser. Optical Coherence Tomography is the optical equivalent of B-mode
      ultrasonography, that consists of a small rotating optical fibre. Both the CLE and OCT
      techniques are minimally invasive and little time consuming. Therefore different areas of the
      lung can be sequentially imaged. With this pilot study the investigators aim to describe
      normal alveolar areas and areas with abnormalities in critically ill patients with non
      resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or
      without bronchoalveolar lavage.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients
time frame: coss sectional (1 day)
description: Percentage of successful imaging
measure: Comparison of pCLE/OCT to radiological patterns
time frame: cross sectional (1 day)
description: Degree of similarity pCLE/OCT-imaging compared to HRCT
measure: Comparison of pCLE/OCT with pathology
time frame: cross sectional (1 day)
description: Degree of similarity between pCLE/OCT characteristics with pathology (in case available)
arm group label: Mechanically ventilated patients
description: Critically ill patients of 18 years or older who receive invasive mechanical ventilation for acute respiratory failure and have an indication for an intervention in the airways.
intervention type: Device
intervention name: Probe based optical techniques
description: During the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT).
arm group label: Mechanically ventilated patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jouke T Annema, MD, PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Marcus J Schultz, MD, PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: Kirsten Kalverda, MD
phone: +31205664356
email: k.a.kalverda@amsterdamumc.nl
last name: Lizzy Wijmans, MD
email: l.wijmans@amsterdamumc.nl
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof J.T. Annema
investigator title: Head of department of pulmonal endoscopy
mesh term: Respiratory Insufficiency
sharing ipd: Undecided
ipd description: We plan to share the data.