Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03252574
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2017-08-15
Brief Title:
A Randomised Crossover Study to Explore the Physiological Impact of AIR Smart Masks on Children
Sponsor:
Innosparks Pte Ltd
Organization:
Innosparks Pte Ltd
Study Overview
Official Title:
To Explore the Physiological Impact of AIR Smart Masks on Children
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 AIRSmart 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 aboveThey 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 Européennes 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-ventilatorFor purposes of this research both CE and NIOSH markings will be made for the masks trialedAs 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 16 - 43mmHg this study defines 30 to 50mmHg as the acceptable range for ETCO2 levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None