Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of blood pressure between the new smartphone App and the radial arterial line
研究概览
简要总结
Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients
详细描述
The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line)
All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days
The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure.
Three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days.
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Intensive care unit patients with an arterial catheter for at least 48 hours
- •Informed Consent as documented by signature
排除标准
- •Patients or families that cannot sign informed consent
- •Patients in emergency situation, and unstable
- •Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
- •Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
- •Known contact dermatitis to nickel/chromium
结局指标
主要结局
Comparison of blood pressure between the new smartphone App and the radial arterial line
时间窗: 48 hours
Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).
次要结局
- Usability assessment(at 48 hour)
研究者
Alexandre Joosten, MD PhD
Study Director
Erasme University Hospital