NCT03875248

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Biospectal · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Blood pressure measurement	Measure optically the blood pressure through the use of a smartphone

Timeline

• Start date: 2019-03-18
• Primary completion: 2021-06-14
• Completion: 2021-06-14
• First posted: 2019-03-14
• Last updated: 2020-06-23

Locations

2 sites across 1 country: Switzerland