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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai hospital, Beijing
  • Jiangsu
    • Taizhou, Jiangsu, China, 225300
      • Taizhou Health Bureau
  • Shanxi
    • Jinzhong, Shanxi, China, 032005
      • Jiexiu Health Bureau
    • Yuncheng, Shanxi, China, 043700
      • Yuanqu Health Bureau
  • Yunnan
    • Qujing, Yunnan, China, 655601
      • Luliang Health Bureau
    • Qujing, Yunnan, China, 655816
      • Luoping Health Bureau
    • Qujing, Yunnan, China, 650000
      • Shizong Health Bureau
    • Qujing, Yunnan, China, 655601
      • Lin Health Duo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Can't fell bitterness; 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.
Can fell bitterness; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
can or can't fell bitterness	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.	Immediately after spray test

Collaborators and Investigators

• Sponsor: Fuwai Yunnan Cardiovascular Hospital
• Investigators: Principal Investigator: Duo lin, Fuwai Yunnan Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2020-KZLXB-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No