Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Blood pressure measurement


Participation Criteria
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Eligibility Criteria
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Arm 1, 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 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. Arm 1, Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The arm 1 of the study has been designed as a multicentric prospective pilot study. The arm 2 of the study has been designed as a monocentric prospective pilot study. The arm 3 of the study has been designed as a monocentric prospective pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1. Blood pressure measurement compared to arterial line<br>Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line). | Device: Blood pressure measurement<br>* Measure optically the blood pressure through the use of a smartphone<br>|
| Other: Arm 2. Blood pressure measurement compared to manual cuff<br>Comparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff). | Device: Blood pressure measurement<br>* Measure optically the blood pressure through the use of a smartphone<br>|
| Other: Arm 3. Blood pressure measurement compared to manual cuff<br>Comparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff). | Device: Blood pressure measurement<br>* Measure optically the blood pressure through the use of a smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of measurement done with the investigational device | Arm 1: Comparision of values to invasive reference method (arterial line) | First 20 minutes | 
| Confirmation of measurement done with the investigational device | Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer) | First 20 minutes | 
| Confirmation of measurement done with the investigational device | Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer) | First 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability assessment | Identification of possible use error in the manipulation of the device and in the performance of the measure | First 20 minutes | 
| Safety of procedure by assessing inconvenience and adverse events | Safety by assessing inconvenience and adverse events. | First 20 minutes |