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
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Overall Respiratory alarm rate per patient per day
研究概览
简要总结
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance Monitoring system within an adult in-patient setting 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. If any heart, respiration rate or skin temperature values move outside of pre-defined high and low limits (individually set for each patient) an alert is raised. ECG arrhythmia detection algorithms automatically record and send ECG data if the patient is suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation, Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device within an adult in-patient setting 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.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female patients, aged 21 years or over
- •Patients admitted to post-operative gynaecological ward at KKH Women's and Children's Hospital, Singapore
- •Patients receiving opioid therapy via patient controlled analgesia (PCA)
- •Patients that are on electronic nursing charting
- •Patients that are on acute pain service monitoring
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 (Heart Rate detection algorithm has not been designed to reject foetal heart rate)
研究组 & 干预措施
Aingeal
All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting.
干预措施: Vital sign monitoring (Device)
结局指标
主要结局
Overall Respiratory alarm rate per patient per day
时间窗: 3-4 days (upon admission till 1-3 days after surgery)
De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
次要结局
- Overall Cardiac alarm rate per patient per day(3-4 days (upon admission till 1-3 days after surgery))
- False positive Respiratory alarm rate per patient per day(3-4 days (upon admission till 1-3 days after surgery))
- False positive Cardiac alarm rate per patient per day(3-4 days (upon admission till 1-3 days after surgery))
研究者
Sng Ban Leong
Head and Senior Consultant, Dept of Women's Anaesthesia
KK Women's and Children's Hospital