<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/NCT04497675</url>
  </required_header>
  <id_info>
    <org_study_id>2020-KZLXB-02-01</org_study_id>
    <nct_id>NCT04497675</nct_id>
  </id_info>
  <brief_title>An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test</brief_title>
  <official_title>An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuwai Yunnan Cardiovascular Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fuwai Yunnan Cardiovascular Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to explore the relationship between the transmission of&#xD;
      respiratory diseases and the correct wearing of masks, as well as the factors affecting the&#xD;
      correct wearing of masks. The research is beneficial to the prevention of respiratory&#xD;
      diseases and moves the barrier of prevention and control forward. It is of great significance&#xD;
      to COVID-19 's practical prevention and control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Overall design：This study uses the methods of cross-sectional survey and chance&#xD;
           sampling.&#xD;
&#xD;
        2. Sign the Informed Consent Form.&#xD;
&#xD;
        3. Investigation on the basic situation of personnel: The gender, age and education level&#xD;
           of the subjects were analyzed as the factors influencing whether the mask was worn&#xD;
           correctly or not.&#xD;
&#xD;
        4. Investigation on the types of wearing masks： 1) The types of masks worn by the subjects&#xD;
           were recorded as the basis of stratified statistics.&#xD;
&#xD;
      2) Mask suitability testing：&#xD;
&#xD;
        1. Visual inspection whether the mask is close to the face with obvious gaps.&#xD;
&#xD;
        2. Breathing test Are there any obvious gaps or whether the cotton around the mask is blown&#xD;
           when the subject taking a deep breath.&#xD;
&#xD;
        3. Spray test The FT-30 qualitative fitness test system of 3M company was used to test the&#xD;
           suitability and correctness of wearing mask.&#xD;
&#xD;
      In the spray test, all subjects underwent a sensitivity test to prove their ability to smell&#xD;
      the bitterness of the reagent, sensitive subjects can participate in the direct spray test.&#xD;
&#xD;
      In order to objectively reflect the overall situation of the subjects, it is necessary to&#xD;
      cover many ages and educational levels of men and women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>can or can't fell bitterness</measure>
    <time_frame>Immediately after spray test</time_frame>
    <description>Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face.&#xD;
If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6000</enrollment>
  <condition>Respiratory Infectious Diseases</condition>
  <arm_group>
    <arm_group_label>Can't fell bitterness</arm_group_label>
    <description>The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively, and the subject can stop the spray as soon as he/she smells bitterness.&#xD;
Record whether the subject feels bitterness, if not, let the subject puts on the hood, carry out the fitness test again and record the results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Can fell bitterness</arm_group_label>
    <description>The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively, and the subject can stop the spray as soon as he/she smells bitterness.&#xD;
If the subject feels bitterness, stick the adhesive strip on the upper edge of the subject's mask and perform the direct spray test again. Record whether the subject feels bitterness, if not, ask the subject to put on the hood, carry out the fitness test again and record it. If there is a feeling, ask the subject to change to a medical surgical mask and put an adhesive strip on the upper edge of the mask, then conduct the direct spray test again, and record the test results.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Those who are 7 years old or above, have the ability of autonomous behavior and language&#xD;
        expression, are willing to take the test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy people with autonomous behavior ability and language expression ability who&#xD;
             are older than or equal to 7 years old, Persons under the age of 18 need to obtain the&#xD;
             consent of their legal guardians；&#xD;
&#xD;
          2. The subjects and / or their legal guardians have the ability to understand the&#xD;
             contents of the study and to participate in all the research processes with the&#xD;
             subjects；&#xD;
&#xD;
          3. People who volunteered to take part in the study；&#xD;
&#xD;
          4. There was no respiratory infection in nearly one month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. People with a history of allergies, including those who are allergic to pollen, dust&#xD;
             mites, etc；&#xD;
&#xD;
          2. People with any history of drug allergy；&#xD;
&#xD;
          3. People who have participated in the experiment are not allowed to participate in this&#xD;
             study for the second time;&#xD;
&#xD;
          4. Pregnant women；&#xD;
&#xD;
          5. The healer after COVID-19 's infection；&#xD;
&#xD;
          6. After questioning, it was found that the subjects were the factors that affected the&#xD;
             study, such as dysosmia, or those who had decreased olfactory ability due to disease,&#xD;
             or facial paralysis, which affected the judgment of the test；&#xD;
&#xD;
          7. Those who are participating in clinical trials of other drugs / devices；&#xD;
&#xD;
          8. Subjects with poor compliance or unwilling to cooperate with the operation as&#xD;
             required；&#xD;
&#xD;
          9. The researchers believe that any other situation that may affect the evaluation of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Duo lin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Yunnan Cardiovascular Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fuwai hospital, Beijing</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Health Bureau</name>
      <address>
        <city>Taizhou</city>
        <state>Jiangsu</state>
        <zip>225300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiexiu Health Bureau</name>
      <address>
        <city>Jinzhong</city>
        <state>Shanxi</state>
        <zip>032005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuanqu Health Bureau</name>
      <address>
        <city>Yuncheng</city>
        <state>Shanxi</state>
        <zip>043700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizong Health Bureau</name>
      <address>
        <city>Qujing</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lin Health Duo</name>
      <address>
        <city>Qujing</city>
        <state>Yunnan</state>
        <zip>655601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luliang Health Bureau</name>
      <address>
        <city>Qujing</city>
        <state>Yunnan</state>
        <zip>655601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luoping Health Bureau</name>
      <address>
        <city>Qujing</city>
        <state>Yunnan</state>
        <zip>655816</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 14, 2020</last_update_submitted>
  <last_update_submitted_qc>October 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04497675/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT04497675/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04497675
org study id: 2020-KZLXB-02-01
nct id: NCT04497675
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to explore the relationship between the transmission of
      respiratory diseases and the correct wearing of masks, as well as the factors affecting the
      correct wearing of masks. The research is beneficial to the prevention of respiratory
      diseases and moves the barrier of prevention and control forward. It is of great significance
      to COVID-19 's practical prevention and control.
1. Overall design：This study uses the methods of cross-sectional survey and chance
           sampling.

        2. Sign the Informed Consent Form.

        3. Investigation on the basic situation of personnel: The gender, age and education level
           of the subjects were analyzed as the factors influencing whether the mask was worn
           correctly or not.

        4. Investigation on the types of wearing masks： 1) The types of masks worn by the subjects
           were recorded as the basis of stratified statistics.

      2) Mask suitability testing：

        1. Visual inspection whether the mask is close to the face with obvious gaps.

        2. Breathing test Are there any obvious gaps or whether the cotton around the mask is blown
           when the subject taking a deep breath.

        3. Spray test The FT-30 qualitative fitness test system of 3M company was used to test the
           suitability and correctness of wearing mask.

      In the spray test, all subjects underwent a sensitivity test to prove their ability to smell
      the bitterness of the reagent, sensitive subjects can participate in the direct spray test.

      In order to objectively reflect the overall situation of the subjects, it is necessary to
      cover many ages and educational levels of men and women.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: can or can't fell bitterness
time frame: Immediately after spray test
description: Whenever the subject feels bitter, it means that the mask does not fit well with the subject's face.
If the subjects do not feel bitter all the time, it means that the mask is suitable for the subjects' face and can be worn.
arm group label: Can't fell bitterness
description: The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively, and the subject can stop the spray as soon as he/she smells bitterness.
Record whether the subject feels bitterness, if not, let the subject puts on the hood, carry out the fitness test again and record the results.
arm group label: Can fell bitterness
description: The subject wears a mask and his/her tongue sticks out properly. The suitability test reagent is used to spray directly to the subject from the top, bottom, left side and right side twice respectively, and the subject can stop the spray as soon as he/she smells bitterness.
If the subject feels bitterness, stick the adhesive strip on the upper edge of the subject's mask and perform the direct spray test again. Record whether the subject feels bitterness, if not, ask the subject to put on the hood, carry out the fitness test again and record it. If there is a feeling, ask the subject to change to a medical surgical mask and put an adhesive strip on the upper edge of the mask, then conduct the direct spray test again, and record the test results.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Duo lin
role: Principal Investigator
affiliation: Fuwai Yunnan Cardiovascular Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No
provided document: 
provided document: 