COVIDNCT04454606
The New Silicone N99 Half-Piece Respirator
A study testing Fit test and Filtration Test in people with COVID and Personal Protective Equipment, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
Trial summary
Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The N95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID, Personal Protective Equipment
- What is being tested?
- Fit test and Filtration Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2020to 31 May 2020
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthcare workers
Who cannot join
- Intolerance to exercise
- cannot taste bitter sensation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bangkok Metroplitan Administration and Vajira Hospital
Bangkok, 10300
About this study
Official title: The New Silicone N99 Half-Piece Respirator:VJR-NMU N99:New and Effective Tool to Prevent COVID-19
Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The N95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more than 95%. It is tightly fit and had high filtration capacity. The widespread pandemic of COVID-19 leads to greater requirement of FFR. A rising in demand would greatly exceed current productive capabilities and stockpiles and would almost certainly result in a robust shortage.
In order to solve these problems, our team had invented a new type of half-piece respirator made from silicone and assembled with hepa or elastostatic filter . A variety of methods have been used to evaluate this new device, including qualitative fit test with Bitrex® test kit and filtration test.
Read the detailed description
As required by Occupational Safety and Health Administration OSHA)[7], the halfpiece respirators need to pass the fittestto identify those individuals who do not achieve the good fit necessary for adequate protection. The performance of this respirator was also determined by measuring percent leakage under constant airflow[8]. The purposes of this study was to evaluate the fitting characteristicof our newly invented silicone N99 respirator and the performance against 30 µm particles using NaCL aerosols. The study was conducted to achieve two specific research objectives
- To investigate the fit characteristic of the novel silicone mask and whether the strap adjustment can help reduce the face-seal leakage
- To determine the level of performance by measure the inward leakage of the generated aerosolswith the new filter and used filter for up to 24 hours.
- Conditions
- COVID, Personal Protective Equipment
- Being tested
- Fit test, Filtration Test
- Keywords
- respirators, n99, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit testDevice
Bitrex Fit Test The Bitrex test uses a person's ability to test a bitter solution to determine whether a respirator fits properly[11]. Each subject was given a taste-threshold screening test prior to each fit test to ensure that he or she could taste. This process was done without subject wearing a respirator. After passing the sensitivity test, the subject will process to 7 steps of fit test as following
- Breathe normally
- Breathe deeply
- Head side to side
- Head up and down
- Bent over wrist, jogging
- Talking
- Breath normally Each step took 60 seconds and the Bitrex solution was refilled into the hood every 30 seconds with half dosage of the amount of the previously test. We asked the participant if he / she could taste the solution during each steps of the test . The test was considered a failure, otherwise, a pass.
Filtration TestDevice
Respirator Performance
The real time respirator performance test method was developed using MT-05U machine (SIBATA model, Saitama, Japan), which measure particle concentrations of diameter 0.03 - 0.06 µm using and particle generator laser beam scattering particle counter that measure particles outside and inside the mask. The ratio between these two values reflected % leak as following:
- leak=((Paticle inside the filter))/((Paticle inside the filter)) x 100 And calculate % filter performance = 100 - % leak We tested at the airflow rate of 40L/min which is 3-4 times higher than normal physiology, assuming that there should be no leakage through the filter. We tested 2 types of filter is CareStar and SafeStar that was incorporated with the silicone mask. CareStar is limited for 24 hour usage and SafeStar is for 72 hour duration.
Study protocol
| Study group | Role | What they receive |
|---|---|---|
| Fit test | Experimental | All the subjects will be tested for fit test Receives: Device: Fit test; Device: Filtration Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit test
pass or fail
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 May 2020
- Primary completion15 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- N99 respirators will be tested in a group of subjects with qualitative fit test.The filters will be tested for filtration test.The results will be considered as pass or fail
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Investigators
- Thananda Trakarnvanich, M.D., Study director, Bangkok Metropolitan Administration and Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454606
- Sponsor's protocol ID
- 053/2563
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011 Jan;62(1):1-13. doi: 10.1016/j.jinf.2010.11.010. Epub 2010 Nov 19.
PubMed 210941845.Occupational Safety and health Administration(OSHA): 29 CFR parts 1910 and 1926 Respiratory Protection: Final Rule. Federal Register 63(5): 1278-1279. Washington, D.C: U.S. Government Printing Office, Office of the Federal Register, January 8,1998.
Coffey C, Zhuang Z, Campbell D. Evaluation of the BitrixTM qualitative fit test method using N95 filtering-facepiece respirators. J Int Soc Respir Prot 1998: 16 : 48-55.
Leung NHL, Chu DKW, Shiu EYC, Chan KH, McDevitt JJ, Hau BJP, Yen HL, Li Y, Ip DKM, Peiris JSM, Seto WH, Leung GM, Milton DK, Cowling BJ. Author Correction: Respiratory virus shedding in exhaled breath and efficacy of face masks. Nat Med. 2020 Jun;26(6):981. doi: 10.1038/s41591-020-0946-9.
PubMed 32461699
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Silicone N99 Half-Piece Respirator:VJR-NMU N99:New and Effective Tool to Prevent COVID-19
- ClinicalTrials.gov ID
- NCT04454606
- Acronym / sponsor ID
- 053/2563
- Conditions
- COVID, Personal Protective Equipment
- Keywords
- respirators, n99, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 1 Jul 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.
Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The N95 mask is the prototype of high efficiency protective device and can effectively protect airborne pathogens of less than 0.3 μm by more than 95%. It is tightly fit and had high filtration capacity. The widespread pandemic of COVID-19 leads to greater requirement of FFR. A rising in demand would greatly exceed current productive capabilities and stockpiles and would almost certainly result in a robust shortage.
In order to solve these problems, our team had invented a new type of half-piece respirator made from silicone and assembled with hepa or elastostatic filter . A variety of methods have been used to evaluate this new device, including qualitative fit test with Bitrex® test kit and filtration test.
Detailed description
As required by Occupational Safety and Health Administration OSHA)[7], the halfpiece respirators need to pass the fittestto identify those individuals who do not achieve the good fit necessary for adequate protection. The performance of this respirator was also determined by measuring percent leakage under constant airflow[8]. The purposes of this study was to evaluate the fitting characteristicof our newly invented silicone N99 respirator and the performance against 30 µm particles using NaCL aerosols. The study was conducted to achieve two specific research objectives
- To investigate the fit characteristic of the novel silicone mask and whether the strap adjustment can help reduce the face-seal leakage
- To determine the level of performance by measure the inward leakage of the generated aerosolswith the new filter and used filter for up to 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- N99 respirators will be tested in a group of subjects with qualitative fit test.The filters will be tested for filtration test.The results will be considered as pass or fail
| Arm | Type | Receives |
|---|---|---|
| Fit test | Experimental | Device: Fit test, Device: Filtration TestAll the subjects will be tested for fit test |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthcare workers
Key exclusion criteria (2 listed)
- Intolerance to exercise
- cannot taste bitter sensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit testBitrex Fit Test The Bitrex test uses a person's ability to test a bitter solution to determine whether a respirator fits properly[11]. Each subject was given a taste-threshold screening test prior to each fit test to ensure that he or she could taste. This process was done without subject wearing a respirator. After passing the sensitivity test, the subject will process to 7 steps of fit test as following * Breathe normally * Breathe deeply * Head side to side * Head up and down * Bent over wrist, jogging * Talking * Breath normally Each step took 60 seconds and the Bitrex solution was refilled into the hood every 30 seconds with half dosage of the amount of the previously test. We asked the participant if he / she could taste the solution during each steps of the test . The test was considered a failure, otherwise, a pass. | Device | Fit test |
| Filtration TestRespirator Performance The real time respirator performance test method was developed using MT-05U machine (SIBATA model, Saitama, Japan), which measure particle concentrations of diameter 0.03 - 0.06 µm using and particle generator laser beam scattering particle counter that measure particles outside and inside the mask. The ratio between these two values reflected % leak as following: * leak=((Paticle inside the filter))/((Paticle inside the filter)) x 100 And calculate % filter performance = 100 - % leak We tested at the airflow rate of 40L/min which is 3-4 times higher than normal physiology, assuming that there should be no leakage through the filter. We tested 2 types of filter is CareStar and SafeStar that was incorporated with the silicone mask. CareStar is limited for 24 hour usage and SafeStar is for 72 hour duration. Study protocol | Device | Fit test |
Primary outcome
Fit test
Time frame: Day 1
pass or fail
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 1 Jul 2020.
- Background: PubMed 21094184Gralton J, Tovey E, McLaws ML, Rawlinson WD. The role of particle size in aerosolised pathogen transmission: a review. J Infect. 2011 Jan;62(1):1-13. doi: 10.1016/j.jinf.2010.11.010. Epub 2010 Nov 19.
- Background5.Occupational Safety and health Administration(OSHA): 29 CFR parts 1910 and 1926 Respiratory Protection: Final Rule. Federal Register 63(5): 1278-1279. Washington, D.C: U.S. Government Printing Office, Office of the Federal Register, January 8,1998.
- BackgroundCoffey C, Zhuang Z, Campbell D. Evaluation of the BitrixTM qualitative fit test method using N95 filtering-facepiece respirators. J Int Soc Respir Prot 1998: 16 : 48-55.
- Results publication: PubMed 32461699Leung NHL, Chu DKW, Shiu EYC, Chan KH, McDevitt JJ, Hau BJP, Yen HL, Li Y, Ip DKM, Peiris JSM, Seto WH, Leung GM, Milton DK, Cowling BJ. Author Correction: Respiratory virus shedding in exhaled breath and efficacy of face masks. Nat Med. 2020 Jun;26(6):981. doi: 10.1038/s41591-020-0946-9.
- Individual participant dataSharing planned: Undecided
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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.
Thananda Trakarnvanich, M.D. study director
Bangkok Metropolitan Administration and Vajira Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit test and Filtration Test in people with COVID and Personal Protective Equipment, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 1 site in Thailand.
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 1 inclusion and 2 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
Fit test (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454606, which also lists 4 linked publications.
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 1 Jul 2020.