Agreement and Precision of a Novel Smartphone Application (OPTIBP) For Continuous Blood Pressure Monitoring: A Comparison With the Invasive Radial Arterial Catheter
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 measurement done with the novel smartphone application versus the reference method
研究概览
简要总结
Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.
详细描述
The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference method, which is the radial arterial line
Patients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)
Patient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).
The placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).
Blood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
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
- •Adult patients in the post-anesthesia care unit after major surgery
- •equipped with an arterial catheters for perioperative management
- •Informed Consent as documented by signature
- •Good understanding of written and oral speaking
排除标准
- •Patients that cannot sign informed consent
- •Patients in emergency situation, are not legally competent, cannot understand the situation
- •Known contact dermatitis to nickel/chromium
- •Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
- •Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
结局指标
主要结局
Comparison of blood pressure measurement done with the novel smartphone application versus the reference method
时间窗: Day of surgery
Comparison of values to invasive reference method (arterial line)
次要结局
- Number of necessary measure to have a good relationship between both methods(Day of surgery)
- Usability assessment(Day of surgery)
研究者
Alexandre Joosten, MD PhD
Principal Investigator
Erasme University Hospital