A Study to Explore the Physiological Impact of AIR+ KN95 Masks on Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- End-tidal Carbon Dioxide
研究概览
简要总结
The primary objective is to evaluate the physiological impact of AIR+ KN95 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, the investigators will assess the general well-being and comfort level of the child when wearing the AIR+ KN95 Mask.
详细描述
There is potential for severe haze episodes to occur in Singapore, and the main air pollutant in the event of haze is particulate matter (PM). Short-term exposure (continuous exposure to unhealthy daily average PSI levels over a period of a few days) to haze like the pattern seen in Singapore may cause irritation of the eyes, nose, and throat in healthy individuals. Haze particles can also affect the heart and lungs, especially in people who already have chronic heart or lung disease e.g., asthma, chronic obstructive pulmonary disease (COPD), or heart failure.
Haze is a perennial problem in Singapore. Commercially available disposable particulate respirators are typically certified for surgical and occupational use. The test standards are specified according to adult breathing conditions and fit. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5), an air pollutant found in transboundary smoke haze.
Commercially available disposable particulate respirators are typically certified under the NIOSH and CE EN 149:2001+A1:2009 standards for surgical and occupational use. These respiratory masks are tested to filter particulate matter in the air with varying degrees of filtering efficiencies according to the respective categories, e.g. NIOSH KN95 certifies respirators to filter at least 95% of non-oil particulates. The test standards are specified according to adult breathing conditions and fit.
Children's respiratory minute volume and rate are different from adults. As commercially available disposable masks designed for occupational use are mainly for adults, such masks do not fit well on children, they do not serve well as protection against Particulate Matter 2.5 (PM 2.5). As haze is a perennial problem, and there is potential for severe haze episodes to occur again, there is a need to consider the development of disposable particulate respirator with enhanced safety and comfort specific for use in children.
ST Engineering Innosparks Pte. Ltd. developed a new type of disposable particulate respirator (hereon referred to as AIR+ KN95 Mask) that is suitable for use in both adults and children, from ages 7 and above. The masks come in S, M and L sizes, and have been tested according to the KN95 protocol for respirators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 7 and 14 years of age (inclusive)
- •Subjects and their parents or legal guardian must provide their consent/ assent to take part in this study
排除标准
- •Subjects with any known cardiorespiratory conditions (including but not limited to the following: asthma, bronchitis, cystic fibrosis, congenital heart disease, emphysema)
- •Subjects with any known medical conditions that may be exacerbated by strenuous activity, including but not limited to the following: exercise-induced asthma, lower respiratory infection (including pneumonia, bronchitis) in the past 2 weeks, anxiety disorders, diabetes, hypertension, or epilepsy/ seizure disorder
- •Subjects with any physical disability from medical, orthopaedic, or neuromuscular disorders
- •Subjects who have an acute upper respiratory tract infection/ moderately severe rhinitis (i.e. blocked nasal passages) on the day of the study
- •Subjects who may compromise the integrity of the mask fit (e.g. those with excessive facial hair)
结局指标
主要结局
End-tidal Carbon Dioxide
时间窗: Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes
Single-use nasal cannulas used in conjunction with Nomoline™ Adapters connected to a Masimo Rad-97™ Pulse CO-Oximeter™ with NomoLine Capnography to log the End-tidal Carbon Dioxide (ETCO2), respiratory rate (RR) information, oxygen saturation (SpO2) and heart rate (HR).
次要结局
- Oxygen Saturation(Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes)
- Respiratory Rate(Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes)
- Heart Rate(Measured every minute for 24 minutes over 4 segments. 1. Rest with no mask (control)-5minutes 2. Rest with AIR+KN95 mask (intervention) -5minutes 3. Mild exertion without mask (control)-7minutes 4. Mild exertion with AIR+KN95 mask(intervention) -7minutes)