Blood Pressure
Conditions
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.
Interventions
DEVICEBlood pressure measurement
Measure optically the blood pressure through the use of a smartphone
Sponsors
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Biospectal
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of measurement done with the investigational device | First 20 minutes | Arm 1: Comparision of values to invasive reference method (arterial line) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Contacts
Primary ContactPatrick Schoettker
Outcome results
None listed