NCT04894669终止不适用
Convenience Sample Data Collection for INVSENSOR00045
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Form, Fit and Function of INVSENSOR00045.
研究概览
简要总结
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
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
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than or equal to 1 month of age
- •Gestational age greater than 23 weeks
- •Weight less than or equal to 5 kg
- •Subjects with standard of care arterial blood sampling line already in place
排除标准
- •Subjects with underdeveloped skin
- •Subjects with abnormalities at the planned application sites that would interfere with system measurements
- •Subjects with known allergic reactions to foam/rubber products and adhesive tape
- •Subjects with axillary arterial lines
- •Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
研究组 & 干预措施
INVSENSOR00045
Experimental
All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
干预措施: INVSENSOR00045 (Device)
结局指标
主要结局
Form, Fit and Function of INVSENSOR00045.
时间窗: Up to 8 hours per subject.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
次要结局
未报告次要终点
研究者
研究点 (1)
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