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| Name | Class |
|---|---|
| CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1. Blood pressure measurement compared to arterial line | Other | Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line). |
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| Arm 2. Blood pressure measurement compared to manual cuff | Other | Comparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff). |
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| Arm 3. Blood pressure measurement compared to manual cuff | Other | Comparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure measurement | Device | Measure optically the blood pressure through the use of a smartphone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of measurement done with the investigational device | Arm 1: Comparision of values to invasive reference method (arterial line) | First 20 minutes |
| Confirmation of measurement done with the investigational device | Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer) | First 20 minutes |
| Confirmation of measurement done with the investigational device | Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer) | First 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Usability assessment | Identification of possible use error in the manipulation of the device and in the performance of the measure | First 20 minutes |
| Safety of procedure by assessing inconvenience and adverse events |
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Arm 1, Inclusion Criteria:
Arm 1, Exclusion Criteria:
Arm 2, Inclusion Criteria:
Arm 2,Exclusion Criteria:
Arm 3, Inclusion Criteria:
Arm 3,Exclusion Criteria:
Only pregnant women are eligible to take part in the study arm 3. No gender-based eligibility criteria exist for the recruitment of patients in the first and seconf arm of the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Schoettker | Contact | +41 79 556 10 43 | Patrick.Schoettker@chuv.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39927734 | Derived | Almeida P, Cuenoud A, Hoang H, Othenin-Girard A, Salhi N, Kothe A, Christen U, Schoettker P. Accuracy of the smartphone blood pressure measurement solution OptiBP to track blood pressure changes in pregnant women. J Hypertens. 2025 Apr 1;43(4):665-672. doi: 10.1097/HJH.0000000000003956. Epub 2025 Feb 7. | |
| 34139747 | Derived |
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| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010808 | Physical Examination |
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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.
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Safety by assessing inconvenience and adverse events.
| First 20 minutes |
| Hôpital Universitaire de Genève (HUG) | Completed | Geneva | 1205 | Switzerland |
| Degott J, Ghajarzadeh-Wurzner A, Hofmann G, Proenca M, Bonnier G, Lemkaddem A, Lemay M, Christen U, Knebel JF, Durgnat V, Burnier M, Wuerzner G, Schoettker P. Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol. Blood Press Monit. 2021 Dec 1;26(6):441-448. doi: 10.1097/MBP.0000000000000556. |