Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
研究概览
简要总结
For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. As part of the WARD-COPD project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted with AECOPD
排除标准
- •Patient expected not to cooperate
- •Patient allergic to plaster, plastic or silicone
- •Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
结局指标
主要结局
Comparison of pulse rate (beats per minute) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
时间窗: Two hours of monitoring (measurement interval of 15 mins)
Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of peripheral oxygen saturation (percent) measurement with Nonin WristOx 3150 vs standard monitoring (Phillips IntelliVue)
时间窗: Two hours of monitoring (measurement interval of 15 mins)
Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of heart rate (beats per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue)
时间窗: Two hours of monitoring (measurement interval of 15 mins)
Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of respiratory rate (breaths per minute) measurement with Isansys Lifetouch patch vs standard monitoring (Phillips IntelliVue) vs direct observation
时间窗: Two hours of monitoring (measurement interval of 15 mins)
Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the three methods. The BA analysis will correct for repeated measures within each subject if required.
Comparison of systolic and diastolic blood pressure (mmHg) measurement with Meditech BP-05 vs standard monitoring (Phillips IntelliVue)
时间窗: Two hours of monitoring (measurement interval of 15 mins)
Analysed using a Bland Altman (BA) analysis to measure mean difference and limits of agreement between the two methods. The BA analysis will correct for repeated measures within each subject if required.
次要结局
未报告次要终点
研究者
Mikkel Elvekjaer
MD, Principal Investigator
University Hospital Bispebjerg and Frederiksberg