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.
Overview
- Phase
- Not Applicable
- Sponsor
- Biospectal
- Enrollment
- 350
- Locations
- 2
- Primary Endpoint
- Confirmation of measurement done with the investigational device
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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
Outcomes
Primary Outcomes
Confirmation of measurement done with the investigational device
Time Frame: First 20 minutes
Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Secondary Outcomes
- Usability assessment(First 20 minutes)
- Safety of procedure by assessing inconvenience and adverse events(First 20 minutes)
Investigators
Patrick Schoettker
Professor, Head of Anaesthesia Unit
Centre Hospitalier Universitaire Vaudois