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

NCT03875248 | Unknown

• 1 other identifier: BSP 2018/01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 2

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).

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Usability assessment

  First 20 minutes

• Safety of procedure by assessing inconvenience and adverse events

  First 20 minutes

Study Arms (3)

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).

Device: Blood pressure measurement

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).

Device: Blood pressure measurement

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).

Device: Blood pressure measurement

Interventions

Blood pressure measurement DEVICE

Measure optically the blood pressure through the use of a smartphone

Arm 1. Blood pressure measurement compared to arterial line; Arm 2. Blood pressure measurement compared to manual cuff; Arm 3. Blood pressure measurement compared to manual cuff

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

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

Study Sites (2)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Hôpital Universitaire de Genève (HUG)

Geneva, 1205, Switzerland

COMPLETED

Related Publications (2)

• 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.

  PMID: 39927734 DERIVED

• 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.

  PMID: 34139747 DERIVED

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Central Study Contacts

Patrick Schoettker

CONTACT

‭+41 79 556 10 43; Patrick.Schoettker@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Anaesthesia Unit

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 14, 2019
• Study Start: March 18, 2019
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)