Bioburden and Usability Study of the Geelong Mask System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
研究概览
简要总结
AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing to give written informed consent
- •Participants who can read and comprehend written and spoken English
- •Participants who are over 18 years of age
- •Participants who have been diagnosed with OSA
- •Participants who have been established on CPAP for ≥ 6 months
- •Participants currently using a ResMed nasal pillows mask
排除标准
- •Participants who are not able to provide written informed consent
- •Participants who are unable to comprehend written and spoken English
- •Participants who are pregnant
- •Participants who are unsuitable to participate in the study in the opinion of the researcher
- •Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
- •Participants who cannot participate for the duration of the trial
- •Participants who are established on bi-level support therapy
- •Participants who are not established on a ResMed nasal pillows mask
研究组 & 干预措施
CPAP Nasal Mask
Geelong Prototype Mask
干预措施: Geelong Prototype Mask (Device)
结局指标
主要结局
Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
时间窗: 6 weeks
The population of microorganisms on mask components will be measured after 6 weeks of continuous use by a participant on their PAP therapy device to assess the safe replacement interval of the component. The impedance of the mask will also be measured to assess whether the build up of microorganisms on the mask component will affect the usability and effectiveness of the mask. Bioburden and impedance testing will be conducted in a lab environment on return of the prototype mask and components.
次要结局
- Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask(6 weeks)