Clinical trial NCT03875248: Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Biospectal
Sponsor class: INDUSTRY
Collaborators: name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2019-03-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility 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,Exclusion Criteria:

* Patients that cannot sign informed consent
* Patients in emergency situation, are not legally competent, cannot understand the situation
* Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
* Known pregnancy
* Systolic blood pressure difference between two arms \>15mmHg or, diastolic blood pressure difference between two arms \>10mmHg
* Unstable cardiac condition (myocardial infarction \< 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
* Dysrhythmia 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 3, Inclusion Criteria:

* Informed Consent as documented by signature
* Pregnant women older than 18 years old
* Good understanding of written and oral speaking used at the centre where the study will be carried out
* Scheduled for a prepartum anesthesia consultation at the hospital maternity unit

Arm 3,Exclusion Criteria:

* Patients that cannot sign informed consent
* Patients in emergency situation, are not legally competent, cannot understand the situation
* Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
* Systolic blood pressure difference between two arms \>15mmHg or, diastolic blood pressure difference between two arms \>10mmHg
* Unstable cardiac condition (myocardial infarction \< 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
* Dysrhythmia 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.

Primary outcomes:
measure: Confirmation of measurement done with the investigational device
timeFrame: First 20 minutes
measure: Confirmation of measurement done with the investigational device
timeFrame: First 20 minutes
measure: Confirmation of measurement done with the investigational device
timeFrame: First 20 minutes
Secondary outcomes:
measure: Usability assessment
timeFrame: First 20 minutes
measure: Safety of procedure by assessing inconvenience and adverse events
timeFrame: First 20 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
city: Genève
country: Switzerland
facility: Hôpital Universitaire de Genève (HUG)
Study officials:
References:
citation: 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.