<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04454606</url>
  </required_header>
  <id_info>
    <org_study_id>053/2563</org_study_id>
    <nct_id>NCT04454606</nct_id>
  </id_info>
  <brief_title>The New Silicone N99 Half-Piece Respirator</brief_title>
  <official_title>The New Silicone N99 Half-Piece Respirator:VJR-NMU N99:New and Effective Tool to Prevent COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangkok Metropolitan Administration Medical College and Vajira Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangkok Metropolitan Administration Medical College and Vajira Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Filter facepiece respirator (FFR) is a critical equipment to prevent the transmission of&#xD;
      respiratory tract infection disease especially the dreadful corona virus 2(SARs-CoV-2).The&#xD;
      N95 mask is the prototype of high efficiency protective device and can effectively protect&#xD;
      airborne pathogens of less than 0.3 μm by more than 95%. It is tightly fit and had high&#xD;
      filtration capacity. The widespread pandemic of COVID-19 leads to greater requirement of FFR.&#xD;
      A rising in demand would greatly exceed current productive capabilities and stockpiles and&#xD;
      would almost certainly result in a robust shortage.&#xD;
&#xD;
      In order to solve these problems, our team had invented a new type of half-piece respirator&#xD;
      made from silicone and assembled with hepa or elastostatic filter . A variety of methods have&#xD;
      been used to evaluate this new device, including qualitative fit test with Bitrex® test kit&#xD;
      and filtration test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As required by Occupational Safety and Health Administration OSHA)[7], the halfpiece&#xD;
      respirators need to pass the fittestto identify those individuals who do not achieve the good&#xD;
      fit necessary for adequate protection. The performance of this respirator was also determined&#xD;
      by measuring percent leakage under constant airflow[8]. The purposes of this study was to&#xD;
      evaluate the fitting characteristicof our newly invented silicone N99 respirator and the&#xD;
      performance against 30 µm particles using NaCL aerosols. The study was conducted to achieve&#xD;
      two specific research objectives&#xD;
&#xD;
        1. To investigate the fit characteristic of the novel silicone mask and whether the strap&#xD;
           adjustment can help reduce the face-seal leakage&#xD;
&#xD;
        2. To determine the level of performance by measure the inward leakage of the generated&#xD;
           aerosolswith the new filter and used filter for up to 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fit test</measure>
    <time_frame>Day 1</time_frame>
    <description>pass or fail</description>
  </primary_outcome>
  <other_outcome>
    <measure>Filtration test</measure>
    <time_frame>Day 1</time_frame>
    <description>percent leakage less than1 percent</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>COVID</condition>
  <condition>Personal Protective Equipment</condition>
  <arm_group>
    <arm_group_label>Fit test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the subjects will be tested for fit test</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fit test</intervention_name>
    <description>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&#xD;
Breathe normally&#xD;
Breathe deeply&#xD;
Head side to side&#xD;
Head up and down&#xD;
Bent over wrist, jogging&#xD;
Talking&#xD;
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.</description>
    <arm_group_label>Fit test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtration Test</intervention_name>
    <description>Respirator Performance&#xD;
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:&#xD;
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.&#xD;
Study protocol</description>
    <arm_group_label>Fit test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthcare workers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance to exercise&#xD;
&#xD;
          -  cannot taste bitter sensation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thananda Trakarnvanich, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Bangkok Metropolitan Administration and Vajira Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bangkok Metroplitan Administration and Vajira Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10300</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21094184</PMID>
  </reference>
  <reference>
    <citation>5.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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>32461699</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangkok Metropolitan Administration Medical College and Vajira Hospital</investigator_affiliation>
    <investigator_full_name>Thananda Trakarnvanich</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>respirators</keyword>
  <keyword>n99</keyword>
  <keyword>COVID-19</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454606
org study id: 053/2563
nct id: NCT04454606
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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

        1. To investigate the fit characteristic of the novel silicone mask and whether the strap
           adjustment can help reduce the face-seal leakage

        2. 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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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
primary purpose: Prevention
masking: None (Open Label)
measure: Fit test
time frame: Day 1
description: pass or fail
measure: Filtration test
time frame: Day 1
description: percent leakage less than1 percent
arm group label: Fit test
arm group type: Experimental
description: All the subjects will be tested for fit test
intervention type: Device
intervention name: Fit test
description: 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.
arm group label: Fit test
intervention type: Device
intervention name: Filtration Test
description: 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
arm group label: Fit test
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thananda Trakarnvanich, M.D.
role: Study Director
affiliation: Bangkok Metropolitan Administration and Vajira Hospital
facility: 
country: Thailand
citation: 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.
PMID: 21094184
citation: 5.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.
citation: 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.
citation: 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.
PMID: 32461699
responsible party type: Principal Investigator
investigator affiliation: Bangkok Metropolitan Administration Medical College and Vajira Hospital
investigator full name: Thananda Trakarnvanich
investigator title: Associate Professor
sharing ipd: Undecided