Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
Aktiia SA
85 participants
Jun 25, 2024
INTERVENTIONAL
Conditions
Summary
The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.
Eligibility
Inclusion Criteria4
- Subjects aged 21 to 85yo
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the study visit and follow study procedures
- Subjects that have signed the informed consent form.
Exclusion Criteria7
- Amputated index fingers
- Damaged/injured skin at index fingers
- Damaged/injured skin at wrists
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula
- Pregnant women
- Polyneuropathy
Interventions
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06368206