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

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.

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).

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Blood pressure measurement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Schoettker; Phone Number: ‭+41 79 556 10 43; Email: Patrick.Schoettker@chuv.ch

Study Locations

• Switzerland
  • Genève, Switzerland, 1205
    • Completed
    • Hôpital Universitaire de Genève (HUG)
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (Chuv)
      • Contact: Patrick Schoettker; Email: Patrick.Schoettker@chuv.ch
      • Principal Investigator: Patrick Schoettker
      • Sub-Investigator: Gregory Hofmann
      • Sub-Investigator: Grégoire Wuerzner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Arm 1. Blood pressure measurement compared to arterial line; Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).	Device: Blood pressure measurement; Measure optically the blood pressure through the use of a smartphone
OTHER: Arm 2. Blood pressure measurement compared to manual cuff; Comparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff).	Device: Blood pressure measurement; Measure optically the blood pressure through the use of a smartphone
OTHER: Arm 3. Blood pressure measurement compared to manual cuff; Comparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff).	Device: Blood pressure measurement; Measure optically the blood pressure through the use of a smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Safety by assessing inconvenience and adverse events.	First 20 minutes

Collaborators and Investigators

• Sponsor: Biospectal
• Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ANTICIPATED): June 14, 2021
• Study Completion (ANTICIPATED): June 14, 2021

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BSP 2018/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No