<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/NCT04400734</url>
  </required_header>
  <id_info>
    <org_study_id>2020.200</org_study_id>
    <nct_id>NCT04400734</nct_id>
  </id_info>
  <brief_title>Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study</brief_title>
  <official_title>Esophagogastroduodenoscopy (EGD) is an Aerosol-generating Procedure: Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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 disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in&#xD;
      March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD)&#xD;
      is a aerosol-generating procedure (AGP) has brought controversy. Multiple international&#xD;
      guidelines consider EGD as AGP based on expert consensus. No scientific data has been&#xD;
      published regarding this. With a commercially available particle counter, we can&#xD;
      differentiate the particle counts of different sizes in different areas of the endoscopy&#xD;
      room. An increase from baseline particles of &lt; 5um during or after the procedure would&#xD;
      suggest that the procedure is an AGP. The baseline particle counts before and during the&#xD;
      procedure are also recorded. The details of the procedure including procedure time and the&#xD;
      use of sedation are also documented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in&#xD;
      March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD)&#xD;
      is a aerosol-generating procedure (AGP) has brought controversy. Multiple international&#xD;
      guidelines consider EGD as AGP based on expert consensus. No scientific data has been&#xD;
      published regarding this. Currently, the term droplet is often taken to refer to droplets &gt;5&#xD;
      microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are&#xD;
      transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei&#xD;
      refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods&#xD;
      of time, allowing them to be transmitted over distances &gt;1 metre. With a commercially&#xD;
      available particle counter, we can differentiate the particle counts of different sizes in&#xD;
      different areas of the endoscopy room. An increase from baseline particles of &lt; 5um during or&#xD;
      after the procedure would suggest that the procedure is an AGP. With the use of a commercial&#xD;
      available particle counter, the number of particles of size (0.3um, 0.5um, 0.7um, 1um, 5um&#xD;
      and 1um) are recorded. The baseline particle counts before and during the procedure are also&#xD;
      recorded. The details of the procedure including procedure time and the use of sedation are&#xD;
      also documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of sedation</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of continuous suction</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Aerosol-generating Procedure, Esophagogastroduodenoscopy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, observational study</intervention_name>
    <description>no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin, Hong&#xD;
        Kong will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing EGD in the endoscopy unit of Prince of wales Hospital, Shatin,&#xD;
             Hong Kong&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  EGD cannot be completed due to patient's condition&#xD;
&#xD;
          -  Patients who are unstable and require extra medical attention&#xD;
&#xD;
          -  Patients who refuse&#xD;
&#xD;
          -  Patients who are not fit for consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shannon Chan, FRCSEd</last_name>
    <phone>852-35052627</phone>
    <email>shannonchan@surgery.cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philip Chiu, FRCSEd</last_name>
    <phone>852-35052627</phone>
    <email>philipchiu@surgery.cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Chinese University of hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shannon Chan, FRCSEd</last_name>
      <phone>852-35052627</phone>
      <email>shannonchan@surgery.cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Philip Chiu, FRCSEd</last_name>
      <phone>852-35052627</phone>
      <email>philipchiu@surgery.cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>CHAN SHANNON MELISSA</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04400734
org study id: 2020.200
nct id: NCT04400734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in
      March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD)
      is a aerosol-generating procedure (AGP) has brought controversy. Multiple international
      guidelines consider EGD as AGP based on expert consensus. No scientific data has been
      published regarding this. With a commercially available particle counter, we can
      differentiate the particle counts of different sizes in different areas of the endoscopy
      room. An increase from baseline particles of < 5um during or after the procedure would
      suggest that the procedure is an AGP. The baseline particle counts before and during the
      procedure are also recorded. The details of the procedure including procedure time and the
      use of sedation are also documented.
The disease COVID-19 has been classified as pandemic by World Health Organisation (WHO) in
      March 2020. This poses a risk to healthcare workers. Whether esophagogastroduodenoscopy (EGD)
      is a aerosol-generating procedure (AGP) has brought controversy. Multiple international
      guidelines consider EGD as AGP based on expert consensus. No scientific data has been
      published regarding this. Currently, the term droplet is often taken to refer to droplets >5
      microns (μm) in diameter that fall rapidly to the ground under gravity, and therefore are
      transmitted only over a limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei
      refers to droplets ≤5 μm in diameter that can remain suspended in air for significant periods
      of time, allowing them to be transmitted over distances >1 metre. With a commercially
      available particle counter, we can differentiate the particle counts of different sizes in
      different areas of the endoscopy room. An increase from baseline particles of < 5um during or
      after the procedure would suggest that the procedure is an AGP. With the use of a commercial
      available particle counter, the number of particles of size (0.3um, 0.5um, 0.7um, 1um, 5um
      and 1um) are recorded. The baseline particle counts before and during the procedure are also
      recorded. The details of the procedure including procedure time and the use of sedation are
      also documented.
observational model: Cohort
time perspective: Prospective
measure: The increase in particle counts of particle size (0.3um, 0.5um, 0.7um, 1um, 5um, 10um) during the procedure
time frame: during the procedure
measure: Procedure time
time frame: during the procedure
measure: Use of sedation
time frame: during the procedure
measure: Use of continuous suction
time frame: during the procedure
intervention type: Other
intervention name: No intervention, observational study
description: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shannon Chan, FRCSEd
phone: 852-35052627
email: shannonchan@surgery.cuhk.edu.hk
last name: Philip Chiu, FRCSEd
phone: 852-35052627
email: philipchiu@surgery.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: CHAN SHANNON MELISSA
investigator title: Assistant Professor
sharing ipd: No