<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/NCT04479592</url>
  </required_header>
  <id_info>
    <org_study_id>2020.200.2</org_study_id>
    <nct_id>NCT04479592</nct_id>
  </id_info>
  <brief_title>Colonoscopy is an Aerosol Generating Procedure</brief_title>
  <official_title>Colonoscopy is an Aerosol-generating Procedure and Water-immersion Technique May Decrease the Amount of Aerosol Generated</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>
      With a commercially available particle counter, we can differentiate the particle counts of&#xD;
      different sizes in different areas of the endoscopy room. An increase from baseline particles&#xD;
      of &lt; 5um during or after the procedure would suggest that the procedure is an AGP.&#xD;
&#xD;
      In this study, the particle counter from Met One Instruments model GT-526S will be used. A&#xD;
      particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and&#xD;
      at the level of the endoscopy nurse assistant's face The change in the particles of different&#xD;
      sizes would be simultaneously recorded. The results of these three locations are compared to&#xD;
      baseline and compared with each other&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, the term droplet is often taken to refer to droplets &gt;5 microns (μm) in diameter&#xD;
      that fall rapidly to the ground under gravity, and therefore are transmitted only over a&#xD;
      limited distance (e.g. ≤1 m). In contrast, the term droplet nuclei refers to droplets ≤5 μm&#xD;
      in diameter that can remain suspended in air for significant periods of time, allowing them&#xD;
      to be transmitted over distances &gt;1 metre. With a commercially available particle counter, we&#xD;
      can 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.&#xD;
&#xD;
      In this study, the particle counter from Met One Instruments model GT-526S will be used. The&#xD;
      study will be conducted in the Prince of Wales Hospital endoscopy centre. A particle sizer is&#xD;
      placed within 10cm of the anus, at the level of the endoscopists' face and at the level of&#xD;
      the endoscopy nurse assistant's face The change in the particles of different sizes would be&#xD;
      simultaneously recorded. The results of these three locations are compared to baseline and&#xD;
      compared with each other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Concentration of aerosol generated during the procedure</measure>
    <time_frame>During the procedure</time_frame>
    <description>Concentration of aerosol generated during the procedure</description>
  </primary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>To See if Colonoscopy is an Aerosol-generating Procedure and to Identify Ways to Minimise the Aerosol Generated</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Particle counter</intervention_name>
    <description>Particle counter to measure the aerosol generated</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All patients who are planned for colonoscopy in the Prince of Wales Hospital, Hong kong&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients where a flexible sigmoidoscopy was plannned Patients where the procedure was&#xD;
             done in a negative pressure room Patients where the procedure was done in an endoscopy&#xD;
             room other than the designated rooms Patients where the procedure was done under&#xD;
             general anaesthesia&#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_official>
    <last_name>Shannon M Chan, FRCSEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shannon M Chan, FRCSEd</last_name>
    <phone>35052627</phone>
    <email>shannonchan@surgery.cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philip Chiu, FRCSEd</last_name>
    <phone>35052627</phone>
    <email>philipchiu@surgery.cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>00000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shannon M Chan, FRCS</last_name>
      <phone>852-35052627</phone>
      <email>shannonchan@surgery.cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 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>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>CHAN SHANNON MELISSA</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Aerosol-generating procedure</keyword>
  <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/NCT04479592
org study id: 2020.200.2
nct id: NCT04479592
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.

      In this study, the particle counter from Met One Instruments model GT-526S will be used. A
      particle sizer is placed within 10cm of the anus, at the level of the endoscopists' face and
      at the level of the endoscopy nurse assistant's face The change in the particles of different
      sizes would be simultaneously recorded. The results of these three locations are compared to
      baseline and compared with each other
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.

      In this study, the particle counter from Met One Instruments model GT-526S will be used. The
      study will be conducted in the Prince of Wales Hospital endoscopy centre. A particle sizer is
      placed within 10cm of the anus, at the level of the endoscopists' face and at the level of
      the endoscopy nurse assistant's face The change in the particles of different sizes would be
      simultaneously recorded. The results of these three locations are compared to baseline and
      compared with each other.
observational model: Cohort
time perspective: Prospective
measure: Concentration of aerosol generated during the procedure
time frame: During the procedure
description: Concentration of aerosol generated during the procedure
intervention type: Other
intervention name: Particle counter
description: Particle counter to measure the aerosol generated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shannon M Chan, FRCSEd
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Shannon M Chan, FRCSEd
phone: 35052627
email: shannonchan@surgery.cuhk.edu.hk
last name: Philip Chiu, FRCSEd
phone: 35052627
email: philipchiu@surgery.cuhk.edu.hk
facility: 
status: Recruiting
contact: 
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