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).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
350
Measure optically the blood pressure through the use of a smartphone
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
RECRUITINGHôpital Universitaire de Genève (HUG)
Geneva, Switzerland
COMPLETEDConfirmation of measurement done with the investigational device
Arm 1: Comparision of values to invasive reference method (arterial line)
Time frame: First 20 minutes
Confirmation of measurement done with the investigational device
Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Time frame: First 20 minutes
Confirmation of measurement done with the investigational device
Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Time frame: First 20 minutes
Usability assessment
Identification of possible use error in the manipulation of the device and in the performance of the measure
Time frame: First 20 minutes
Safety of procedure by assessing inconvenience and adverse events
Safety by assessing inconvenience and adverse events.
Time frame: First 20 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.