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

Blood Pressure Clinical Trial

— OPTIBP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03875248
• Other study ID #: BSP 2018/01
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2020
• Source: Biospectal
• Contact: Patrick Schoettker
• Phone: ?+41 79 556 10 43
• Email: Patrick.Schoettker[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Blood pressure measurement
Measure optically the blood pressure through the use of a smartphone

Locations

Country	Name	City	State
Switzerland	Hôpital Universitaire de Genève (HUG)	Genève
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Biospectal	CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation of measurement done with the investigational device	Arm 1: Comparision of values to invasive reference method (arterial line)	First 20 minutes
Primary	Confirmation of measurement done with the investigational device	Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)	First 20 minutes
Primary	Confirmation of measurement done with the investigational device	Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)	First 20 minutes
Secondary	Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure	First 20 minutes
Secondary	Safety of procedure by assessing inconvenience and adverse events	Safety by assessing inconvenience and adverse events.	First 20 minutes