NCT06093373已完成不适用
Feasibility Study to Evaluate a New Hands-free Doppler Heart Rate Monitor Normally Used to Measure the Fetal Heart Rate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The accuracy of the system in 15 patients, when compared with the gold standard ECG
研究概览
简要总结
The study is an exploratory research study looking at the feasibility, acceptability and accuracy of a doppler device compared with the gold standard ECG. It will take place in the sleep unit at Sheffield Children's Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have been referred for a cardio-respiratory polygraphy sleep study.
- •Patients aged one month up to one year old.
排除标准
- •Subjects whose parents/legal guardians/carers are not fluent in English, or who have special communication needs.
- •Child anticipated to become distressed with additional sensor.
- •Child too clinically unwell to take part (as decided by clinical staff).
结局指标
主要结局
The accuracy of the system in 15 patients, when compared with the gold standard ECG
时间窗: 1 hour
The acceptability of the sensor to the child as viewed by the parent
时间窗: 1 hour
As measured by researcher designed questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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