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An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497675
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fuwai Yunnan Cardiovascular Hospital

Brief Summary:
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.

Condition or disease
Respiratory Infectious Diseases

Detailed Description:
  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.

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Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Group/Cohort
Can't fell bitterness
  1. 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.
  2. 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.
Can fell bitterness
  1. 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.
  2. 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.



Primary Outcome Measures :
  1. can or can't fell bitterness [ Time Frame: Immediately after spray test ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Those who are 7 years old or above, have the ability of autonomous behavior and language expression, are willing to take the test.
Criteria

Inclusion Criteria:

  1. Healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, Persons under the age of 18 need to obtain the consent of their legal guardians;
  2. The subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects;
  3. People who volunteered to take part in the study;
  4. There was no respiratory infection in nearly one month.

Exclusion Criteria:

  1. People with a history of allergies, including those who are allergic to pollen, dust mites, etc;
  2. People with any history of drug allergy;
  3. People who have participated in the experiment are not allowed to participate in this study for the second time;
  4. Pregnant women;
  5. The healer after COVID-19 's infection;
  6. After questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test;
  7. Those who are participating in clinical trials of other drugs / devices;
  8. Subjects with poor compliance or unwilling to cooperate with the operation as required;
  9. The researchers believe that any other situation that may affect the evaluation of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04497675


Locations
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China, Beijing
Fuwai hospital, Beijing
Beijing, Beijing, China, 100037
China, Jiangsu
Taizhou Health Bureau
Taizhou, Jiangsu, China, 225300
China, Shanxi
Jiexiu Health Bureau
Jinzhong, Shanxi, China, 032005
Yuanqu Health Bureau
Yuncheng, Shanxi, China, 043700
China, Yunnan
Shizong Health Bureau
Qujing, Yunnan, China, 650000
Lin Health Duo
Qujing, Yunnan, China, 655601
Luliang Health Bureau
Qujing, Yunnan, China, 655601
Luoping Health Bureau
Qujing, Yunnan, China, 655816
Sponsors and Collaborators
Fuwai Yunnan Cardiovascular Hospital
Investigators
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Principal Investigator: Duo lin Fuwai Yunnan Cardiovascular Hospital
  Study Documents (Full-Text)

Documents provided by Fuwai Yunnan Cardiovascular Hospital:
Informed Consent Form  [PDF] June 18, 2020

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Responsible Party: Fuwai Yunnan Cardiovascular Hospital
ClinicalTrials.gov Identifier: NCT04497675    
Other Study ID Numbers: 2020-KZLXB-02-01
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection