Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Heart rate comparison
研究概览
简要总结
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
详细描述
RENEW's Surveillance Monitoring system is made up of two main components:
a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted by the devices intermittently to the Surveillance Station, enabling vital signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main tertiary women and children hospital in Singapore. In the paediatric population, assessment of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from single lead ECG and at deriving respiratory rate when compared against a commonly used vital signs monitor. User acceptance of Aingeal and the Surveillance System will be considered within the clinical settings.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female paediatric patients, aged between 3 and 17 years
- •Patients attending outpatient care at KK Women's and Children's Hospital, Singapore
排除标准
- •Patients with active, implantable devices (such as a pacemaker or ICD)
- •Patients with any skin condition or injury affecting the electrode placement site
- •Patients that are pregnant
- •Those patients who, in the opinion of the clinic staff, are not suitable to participate.
结局指标
主要结局
Heart rate comparison
时间窗: 15 minutes
Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
次要结局
- Respiratory rate comparison(15 minutes)
研究者
Low Bao Bei Kelly
Associate Consultant, Department of Paediatrics
KK Women's and Children's Hospital