Preliminary Multi-centric Clinical Study Assessing the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for the Continuous Monitoring and Recording of Vital Physiological Parameters on Infants and Young Children by Comparison of Simultaneous Polysomnographic Recording During Standard of Care Hospitalisation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 3
- 主要终点
- to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB
研究概览
简要总结
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep. After the test, data from the device and from the PSG (HR, SpO2, BR) will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values (ECG, Oximeter, belly belt). In a second analysis, the aim is to improve the accuracy of the GBB algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants and children under 5 years of age
- •PSG is required per standard of care
- •Signature of consent form
排除标准
- •Children having already done the PSG wearing GBB for this study
- •Epileptic children (due to high motion/artifacts during sleep)
- •Weight below 2.5 kg
结局指标
主要结局
to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB
时间窗: 12 hours
The primary objective of this pilot study is to improve the calibration, the correctness and reproducibility of the measurements reported by the GBB compared to a standard of care for measuring SpO2 (%) through the recording of raw data with the Gabi Baby Band in parallel with values recorded by medical devices used by the investigation site in its current standard care practice test (during sleep) on infants and children under 5 years old.
次要结局
- to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB(12 hours)
- to improve the calibration, the correctness and reproducibility of the measurements of the HR (heart rate; beat/min or bpm) reported by the GBB(12 hours)