Respiratory Infectious DiseasesNCT04497675
An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test
An observational study of Respiratory Infectious Diseases, run by Fuwai Yunnan Cardiovascular Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infectious Diseases
- How many people
- 6,000 participants
- Where
- 8 sitesChina
- Study dates
- 19 Jun 2020to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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；
- 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；
- People who volunteered to take part in the study；
- There was no respiratory infection in nearly one month.
Who cannot join
- People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
- People with any history of drug allergy；
- People who have participated in the experiment are not allowed to participate in this study for the second time;
- Pregnant women；
- The healer after COVID-19 's infection；
- 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；
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- Those who are participating in clinical trials of other drugs / devices；
- Subjects with poor compliance or unwilling to cooperate with the operation as required；
- The researchers believe that any other situation that may affect the evaluation of the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Fuwai hospital, Beijing
Beijing, Beijing Municipality, 100037
Jiexiu Health Bureau
Jinzhong, Shanxi, 032005
Shizong Health Bureau
Qujing, Yunnan, 650000
Lin Health Duo
Qujing, Yunnan, 655601
Luliang Health Bureau
Qujing, Yunnan, 655601
Luoping Health Bureau
Qujing, Yunnan, 655816
Taizhou Health Bureau
Taizhou, Jiangsu, 225300
Yuanqu Health Bureau
Yuncheng, Shanxi, 043700
About this study
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.
Read the detailed description
- Overall design：This study uses the methods of cross-sectional survey and chance sampling.
- Sign the Informed Consent Form.
- 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.
- Investigation on the types of wearing masks： 1) The types of masks worn by the subjects were recorded as the basis of stratified statistics.
- Mask suitability testing：
- Visual inspection whether the mask is close to the face with obvious gaps.
- Breathing test Are there any obvious gaps or whether the cotton around the mask is blown when the subject taking a deep breath.
- 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.
- Conditions
- Respiratory Infectious Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after spray test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start19 Jun 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuwai Yunnan Cardiovascular Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duo lin, Principal investigator, Fuwai Yunnan Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497675
- Sponsor's protocol ID
- 2020-KZLXB-02-01
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Investigation on Correct Wearing of Mask by Direct Spray Test
- ClinicalTrials.gov ID
- NCT04497675
- Acronym / sponsor ID
- 2020-KZLXB-02-01
- Conditions
- Respiratory Infectious Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Fuwai Yunnan Cardiovascular HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Overall design：This study uses the methods of cross-sectional survey and chance sampling.
- Sign the Informed Consent Form.
- 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.
- Investigation on the types of wearing masks： 1) The types of masks worn by the subjects were recorded as the basis of stratified statistics.
- Mask suitability testing：
- Visual inspection whether the mask is close to the face with obvious gaps.
- Breathing test Are there any obvious gaps or whether the cotton around the mask is blown when the subject taking a deep breath.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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；
- 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；
- People who volunteered to take part in the study；
- There was no respiratory infection in nearly one month.
Key exclusion criteria (9 listed)
- People with a history of allergies, including those who are allergic to pollen, dust mites, etc；
- People with any history of drug allergy；
- People who have participated in the experiment are not allowed to participate in this study for the second time;
- Pregnant women；
- The healer after COVID-19 's infection；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duo lin principal investigator
Fuwai Yunnan Cardiovascular Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infectious Diseases, run by Fuwai Yunnan Cardiovascular Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can or can't fell bitterness (time frame: Immediately after spray test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.