A Randomised Crossover Study to Explore the Physiological Impact of AIR+ Smart Masks on Children
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): A; B
Intervention type(s): Other; Other
Intervention description(s): AIR+ Smart Mask Only; AIR+ Smart Mask with micro-ventilator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other