Status:
UNKNOWN
Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study
Lead Sponsor:
Biospectal
Collaborating Sponsors:
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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 au...
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 an...
Eligibility Criteria
Inclusion
- Arm 1,
- 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
- 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,
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 14 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03875248
Start Date
March 18 2019
End Date
June 14 2021
Last Update
June 23 2020
Active Locations (2)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
2
Hôpital Universitaire de Genève (HUG)
Geneva, Switzerland, 1205