Arm 1: Optical Blood Pressure Monitoring (OptiBP Mobile App), An Accurate Blood Pressure Measurement Compared to Invasive Blood Pressure Measurement. Arm 2 and Arm 3: Improvement and Validation of the Smartphone Blood Pressure Measurement (OptiBP Mobile App). A Prospective, Method Comparison, Proof of Concept Study in a Swiss Population.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Confirmation of measurement done with the investigational device
研究概览
简要总结
Validation of an existing algorithm designed to estimate blood pressure based on collected optical signals on patients against two reference methods, which are the arterial catheter (arm 1) and the ausculatory sphygmomanometer (arm 2).
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 equipments, which are the arterial line and the ausculatory sphygmomanometer .
In the arm 1 of the study, patients scheduled for general anesthesia at the Centre Hospitalier Universitaire Vaudois (CHUV) and at the Hôpitaux Universitaire de Genève (HUG) will be recruited and their pressure will be measured with both mesurement methods. General anesthesia is known to generate significant variations in blood pressure at the time of induction. During the first minutes of anesthesia, the patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment. After the intervention, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
In the arm 2, patients scheduled for a medical appointment at the hypertension unit of the Centre Hospitalier Universitaire Vaudois (CHUV) will be recruited. Their pressure will be measured with the mobile application and with the reference equipment at various time points. After the intervention, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
In the arm 3, patients scheduled for a medical appointment at the maternity unit of the Centre Hospitalier Universitaire Vaudois (CHUV) will be recruited. Their pressure will be measured with the mobile application and with the reference equipment at various time points. After the intervention, the 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
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Men or women older than 18 years old
- •Good understanding of written and oral speaking used at the centre where the study will be carried out
- •American Society of Anesthesiology clinical classification Risk (ASA) Class 1-3
- •Scheduled for a general anesthesia
- •Necessitating an arterial catheters for the anesthesia and surgery.
排除标准
- •Patients that cannot sign informed consent
- •Patients in emergency situation, are not legally competent, cannot understand the situation
- •ASA Risk class 4
- •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
- •Arm 2, Inclusion Criteria:
- •Informed Consent as documented by signature
- •Men or women older than 18 years old
- •Good understanding of written and oral speaking used at the centre where the study will be carried out
- •Arm 2,Exclusion Criteria:
- •Patients that cannot sign informed consent
- •Patients in emergency situation, are not legally competent, cannot understand the situation
- •Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
- •Known pregnancy
- •Systolic blood pressure difference between two arms >15mmHg or, diastolic blood pressure difference between two arms >10mmHg
- •Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
- •Dysrhythmia 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.
- •Arm 3, Inclusion Criteria:
- •Informed Consent as documented by signature
- •Pregnant women older than 18 years old
- •Good understanding of written and oral speaking used at the centre where the study will be carried out
- •Scheduled for a prepartum anesthesia consultation at the hospital maternity unit
- •Arm 3,Exclusion Criteria:
- •Patients that cannot sign informed consent
- •Patients in emergency situation, are not legally competent, cannot understand the situation
- •Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
- •Systolic blood pressure difference between two arms >15mmHg or, diastolic blood pressure difference between two arms >10mmHg
- •Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
- •Dysrhythmia 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
Confirmation of measurement done with the investigational device
时间窗: First 20 minutes
Arm 1: Comparision of values to invasive reference method (arterial line)
次要结局
- Usability assessment(First 20 minutes)
- Safety of procedure by assessing inconvenience and adverse events(First 20 minutes)
研究者
Patrick Schoettker
Professor, Head of Anaesthesia Unit
Centre Hospitalier Universitaire Vaudois