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

F

Fuwai Yunnan Cardiovascular Hospital

Status

Completed

Conditions

Respiratory Infectious Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT04497675
2020-KZLXB-02-01

Details and patient eligibility

About

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.

Full 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.
  1. 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.

Enrollment

6,000 patients

Sex

All

Ages

7+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

6,000 participants in 2 patient groups

Can't fell bitterness
Description:
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
Description:
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.

Trial documents
2

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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