<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/NCT03252574</url>
  </required_header>
  <id_info>
    <org_study_id>ISPL-2015/01059</org_study_id>
    <nct_id>NCT03252574</nct_id>
  </id_info>
  <brief_title>A Randomised Crossover Study to Explore the Physiological Impact of AIR+ Smart Masks on Children</brief_title>
  <official_title>To Explore the Physiological Impact of AIR+ Smart Masks on Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innosparks Pte Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Innosparks Pte Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to evaluate the physiological impact of AIR+ Smart Masks on&#xD;
      end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary&#xD;
      outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate&#xD;
      (HR) and respiratory rate (RR). In addition, we will assess the general well-being and&#xD;
      comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that prolonged wearing of disposable particulate respirators may lead to&#xD;
      an increase in carbon dioxide (CO2) levels in the dead space of the respirator as well as in&#xD;
      the re-breathing of the expired air when wearing it. The increased CO2 levels may result in&#xD;
      headaches, increased irritability, and breathing difficulty. In addition, there is some&#xD;
      discomfort due to the accumulation of heat and humid air in the dead space of between the&#xD;
      respirator and face. Innosparks Pte Ltd (formerly, ST Dynamics) (the Advanced Engineering&#xD;
      Centre of ST Engineering) developed a new type of disposable particulate respirator (hereon&#xD;
      referred to as AIR+ Smart Mask) that is suitable for use in both adults and children, from&#xD;
      ages 7 and above.They also designed an optional accompanying device, the micro-ventilator,&#xD;
      which is battery-powered and aims to extract accumulated heat, moisture, and carbon dioxide&#xD;
      from within the mask. Innosparks Pte Ltd (formerly, ST Dynamics) have obtained the US&#xD;
      National Institute for Occupational Safety and Health (NIOSH) N95 certification for the three&#xD;
      sizes of masks without micro-ventilator, and Conformité Européenne's (CE) certification for&#xD;
      the following mask specifications:• FFP1 and NIOSH approved N95 for S and M-sized AIR+ Smart&#xD;
      Masks without micro ventilator;• FFP2 and NIOSH approved N95 for L-sized mask without micro&#xD;
      ventilator;• FFP1 certification for S and M-sized masks with micro-ventilator, and;• FFP2&#xD;
      certification for the L size mask with micro-ventilator.For purposes of this research, both&#xD;
      CE and NIOSH markings will be made for the masks trialed.As the masks were developed&#xD;
      specifically for school-going children, this study is designed to explore whether the new&#xD;
      disposable particulate respirator, which can be attached with a ventilator to vent out&#xD;
      expired air within the respirator, is safe and effective for use in healthy children aged 7&#xD;
      to 14 years of age. This is through measuring the variation of carbon dioxide levels in&#xD;
      children with and without the AIR+ Smart Mask. End-tidal carbon dioxide pressure (ETCO2) is a&#xD;
      good indicator of arterial carbon dioxide pressure (PaCO2) in healthy adults and children,&#xD;
      and has been used for continuous direct assessment of PaCO2 in clinical contexts. The normal&#xD;
      range of PaCO2 is from 35 - 45 mmHg. As there is a slight margin of difference between ETCO2&#xD;
      and PaCO2 values during measurement of about 1.6 +/- 4.3mmHg, this study defines 30 to 50mmHg&#xD;
      as the acceptable range for ETCO2 levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>End Tidal Carbon Dioxide</measure>
    <time_frame>75 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Oxygen Saturation</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>75 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No mask, followed by AIR+ Smart Mask only (A), then AIR+ Smart Mask with micro-ventilator (B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence BA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No mask, followed by AIR+ Smart Mask with micro-ventilator (B), then AIR+ Smart Mask only (A).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A</intervention_name>
    <description>AIR+ Smart Mask Only</description>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_label>Sequence BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>B</intervention_name>
    <description>AIR+ Smart Mask with micro-ventilator</description>
    <arm_group_label>Sequence AB</arm_group_label>
    <arm_group_label>Sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged between 7 and 14 years of age (inclusive)&#xD;
&#xD;
          2. Subjects and their parent/legal guardian must provide the consent and assent as&#xD;
             appropriate to take part in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with any known cardiorespiratory conditions (including but not limited to the&#xD;
             following: asthma, bronchitis, cystic fibrosis, congenital heart disease, emphysema)&#xD;
&#xD;
          2. Subjects with any known medical conditions that may be exacerbated by strenuous&#xD;
             activity, including but not limited to the following: exercise-induced asthma, lower&#xD;
             respiratory infection (including pneumonia, bronchitis) in the past 2 weeks, anxiety&#xD;
             disorders, diabetes, hypertension, or epilepsy/ seizure disorder&#xD;
&#xD;
          3. Subjects with any physical disability from medical, orthopaedic or neuromuscular&#xD;
             disorders&#xD;
&#xD;
          4. Subjects who have an acute upper respiratory tract infection/ moderately severe&#xD;
             rhinitis (i.e. blocked nasal passages) on the day of the study&#xD;
&#xD;
          5. Subjects who may compromise the integrity of the mask fit (e.g. those with excessive&#xD;
             facial hair).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Goh, A/P</last_name>
    <role>Principal Investigator</role>
    <affiliation>NUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innosparks Pte Ltd, 75 Ayer Rajah Crescent, #02-13</name>
      <address>
        <city>Singapore</city>
        <zip>139953</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Roberge RJ, Coca A, Williams WJ, Powell JB, Palmiero AJ. Physiological impact of the N95 filtering facepiece respirator on healthcare workers. Respir Care. 2010 May;55(5):569-77.</citation>
    <PMID>20420727</PMID>
  </reference>
  <reference>
    <citation>Sinkule EJ, Powell JB, Goss FL. Evaluation of N95 respirator use with a surgical mask cover: effects on breathing resistance and inhaled carbon dioxide. Ann Occup Hyg. 2013 Apr;57(3):384-98. doi: 10.1093/annhyg/mes068. Epub 2012 Oct 29.</citation>
    <PMID>23108786</PMID>
  </reference>
  <reference>
    <citation>Ickx B, Dolomie J-0, Benalouch M et al. Arterial to End-tidal carbon dioxide tension differences in infants and children, JACR, 2155-6148 6: 511. doi:10.4172/2155-6148.1000511</citation>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03252574
org study id: ISPL-2015/01059
nct id: NCT03252574
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective is to evaluate the physiological impact of AIR+ Smart Masks on
      end-tidal carbon dioxide (ETCO2) of children aged 7 to 14 years of age. The secondary
      outcomes include other physiological parameters such as oxygen saturation (SPO2), heart rate
      (HR) and respiratory rate (RR). In addition, we will assess the general well-being and
      comfort level of the child when wearing the AIR+Smart Mask with and without micro-ventilator.
Studies have shown that prolonged wearing of disposable particulate respirators may lead to
      an increase in carbon dioxide (CO2) levels in the dead space of the respirator as well as in
      the re-breathing of the expired air when wearing it. The increased CO2 levels may result in
      headaches, increased irritability, and breathing difficulty. In addition, there is some
      discomfort due to the accumulation of heat and humid air in the dead space of between the
      respirator and face. Innosparks Pte Ltd (formerly, ST Dynamics) (the Advanced Engineering
      Centre of ST Engineering) developed a new type of disposable particulate respirator (hereon
      referred to as AIR+ Smart Mask) that is suitable for use in both adults and children, from
      ages 7 and above.They also designed an optional accompanying device, the micro-ventilator,
      which is battery-powered and aims to extract accumulated heat, moisture, and carbon dioxide
      from within the mask. Innosparks Pte Ltd (formerly, ST Dynamics) have obtained the US
      National Institute for Occupational Safety and Health (NIOSH) N95 certification for the three
      sizes of masks without micro-ventilator, and Conformité Européenne's (CE) certification for
      the following mask specifications:• FFP1 and NIOSH approved N95 for S and M-sized AIR+ Smart
      Masks without micro ventilator;• FFP2 and NIOSH approved N95 for L-sized mask without micro
      ventilator;• FFP1 certification for S and M-sized masks with micro-ventilator, and;• FFP2
      certification for the L size mask with micro-ventilator.For purposes of this research, both
      CE and NIOSH markings will be made for the masks trialed.As the masks were developed
      specifically for school-going children, this study is designed to explore whether the new
      disposable particulate respirator, which can be attached with a ventilator to vent out
      expired air within the respirator, is safe and effective for use in healthy children aged 7
      to 14 years of age. This is through measuring the variation of carbon dioxide levels in
      children with and without the AIR+ Smart Mask. End-tidal carbon dioxide pressure (ETCO2) is a
      good indicator of arterial carbon dioxide pressure (PaCO2) in healthy adults and children,
      and has been used for continuous direct assessment of PaCO2 in clinical contexts. The normal
      range of PaCO2 is from 35 - 45 mmHg. As there is a slight margin of difference between ETCO2
      and PaCO2 values during measurement of about 1.6 +/- 4.3mmHg, this study defines 30 to 50mmHg
      as the acceptable range for ETCO2 levels.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: End Tidal Carbon Dioxide
time frame: 75 minutes
measure: Percent Oxygen Saturation
time frame: 75 minutes
measure: Heart Rate
time frame: 75 minutes
measure: Respiratory Rate
time frame: 75 minutes
arm group label: Sequence AB
arm group type: Other
description: No mask, followed by AIR+ Smart Mask only (A), then AIR+ Smart Mask with micro-ventilator (B)
arm group label: Sequence BA
arm group type: Other
description: No mask, followed by AIR+ Smart Mask with micro-ventilator (B), then AIR+ Smart Mask only (A).
intervention type: Other
intervention name: A
description: AIR+ Smart Mask Only
arm group label: Sequence AB
arm group label: Sequence BA
intervention type: Other
intervention name: B
description: AIR+ Smart Mask with micro-ventilator
arm group label: Sequence AB
arm group label: Sequence BA
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Goh, A/P
role: Principal Investigator
affiliation: NUH
facility: 
country: Singapore
citation: Roberge RJ, Coca A, Williams WJ, Powell JB, Palmiero AJ. Physiological impact of the N95 filtering facepiece respirator on healthcare workers. Respir Care. 2010 May;55(5):569-77.
PMID: 20420727
citation: Sinkule EJ, Powell JB, Goss FL. Evaluation of N95 respirator use with a surgical mask cover: effects on breathing resistance and inhaled carbon dioxide. Ann Occup Hyg. 2013 Apr;57(3):384-98. doi: 10.1093/annhyg/mes068. Epub 2012 Oct 29.
PMID: 23108786
citation: Ickx B, Dolomie J-0, Benalouch M et al. Arterial to End-tidal carbon dioxide tension differences in infants and children, JACR, 2155-6148 6: 511. doi:10.4172/2155-6148.1000511
responsible party type: Sponsor