Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study
- Conditions
- Blood Pressure
- Interventions
- Device: Blood pressure measurement
- Registration Number
- NCT03875248
- Lead Sponsor
- Biospectal
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
- 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,
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1. Blood pressure measurement compared to arterial line Blood pressure measurement Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line). Arm 2. Blood pressure measurement compared to manual cuff Blood pressure measurement Comparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff). Arm 3. Blood pressure measurement compared to manual cuff Blood pressure measurement Comparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff).
- Primary Outcome Measures
Name Time Method Confirmation of measurement done with the investigational device First 20 minutes Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
- Secondary Outcome Measures
Name Time Method Usability assessment First 20 minutes Identification of possible use error in the manipulation of the device and in the performance of the measure
Safety of procedure by assessing inconvenience and adverse events First 20 minutes Safety by assessing inconvenience and adverse events.
Trial Locations
- Locations (2)
Hôpital Universitaire de Genève (HUG)
🇨🇭Genève, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Vaud, Switzerland