NCT06715410已完成不适用
CO2 Pilot Clinical Investigation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Collection of data
研究概览
简要总结
The investigational device enables monitoring of EtCO2, FiCO2 and respiration rate values.
The purpose of this clinical study is to collect parameter raw data for development, evaluate the operational and functional features of the investigational device as well as ease of use of the system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and pediatric patients that are endotracheally intubated, tracheostomized or have a laryngeal mask or similar
- •Tolerate airway adapter dead space of 6.7 ml
- •Are above 10 kg
- •2 years of age of older
- •Able to provide written informed consent or have a LDR to provide written informed consent
- •Are being cared for in hospital unit and are expected to remain in the unit for the duration of the study procedure
排除标准
- •Are known to be pregnant
- •Are breastfeeding
- •Are suffering from infection(s) or immunocompromised patients that require isolation.
- •PI or designee decision due to subject health condition
结局指标
主要结局
Collection of data
时间窗: From admission to discharge, maximum of 48 hours
Raw parameter data will be collected from subjects in clinical settings.
次要结局
- Evaluation of the performance and usability of CO2 measurement(From admission to discharge, maximum of 48 hours)
研究者
研究点 (2)
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