Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Study Overview
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Brief Summary
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During the last couple of years, a growing number of wearable devices evolved to provide accurate, cheap and non-invasive monitoring of vitals parameters.This connected care technology could be helpful for treatment and care during a pandemic such as COVID-19. The use of these non-invasive remote monitoring devices can help health care providers to assess patient's vital signs and symptom progression, reducing reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.

Detailed Description
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Several cuff-less blood pressure monitoring devices have emerged in patient care using photoplethysmography. PPG utilizes an infrared or visible light to measure peripheral volumetric variations of blood circulation and its waveform has been proven to have a good correlation with BP waveform.Nonetheless, the accuracy of these instruments is of fundamental importance. Several validation procedures for assessing the precision of BP monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, International Organization for Standardization and European Society of Hypertension. Adherence to these guidelines are essential to ensure the effectiveness of BP measurement of the wearable devices. Therefore, the investigators propose to test wearable low-noise, low-power SENBIOSYS photoplethysmography signals for estimation of BP.

Official Title
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Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: Senbiosys


Participation Criteria
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Eligibility Criteria
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Participants fulfilling the following inclusion criteria are eligible for the study: Age ≥ 18 years Patients referred for coronarography Patient in the intensive care unit requiring invasive blood pressure monitoring and with an arterial catheter in place at the time of inclusion to the study The presence of any of the following exclusion criteria will lead to exclusion of the participant: Unable or unwilling to provide written informed consent Coronarography in patients with myocardial infarction Patient with suspected or certified COVID-infection Patients with atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized measures in the cardiac catheterization laborator<br>Immediately after coronary angiography, intra-arterial BP waveforms will be recorded using a fluid-filled catheter via right femoral or radial access. The catheter will be flushed before any waveform recordings is made. At first, the catheter will be positioned in the aorta for 3 minutes of stable BP waveforms recording. Intracoronary nitroglycerin will be administered at a dose of 300 µg, newly preceding 3 minute of recording. At the end of the coronary angiography, additional 3 minutes of recording will be performed in the aorta. | Device: Senbiosys<br>* The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.<br>|
| Experimental: Standardized measures in the intensive care unit<br>Invasive BP monitoring is a commonly used technique in the ICU and is used to guide many intensive care unit therapies. Enrolled patients must have had an arterial catheter in place at the time of inclusion to the study. Arterial catheterization will be performed by the intensive care team according to current medical guidelines. No arterial catheters were placed for the sole purpose of this study. The Senbiosys device will be placed on the opposite arm of the arterial catheter for simultaneous measurements. | Device: Senbiosys<br>* The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of non-invasive BP monitors: blood pressure | The primary outcome is the assessment of mean bias (± 95% CI or precision of bias) for systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MBP) between invasive and non-invasive BP measurements. The standard deviation of the bias (±95% limits of agreement), will be assessed for SBP, DBP, and MBP measurements. | 10 to 15 minutes per patient (once) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of signal with artefact, | Secondary outcomes include reliability index (Qualification Index QI) for blood pressure epochs and count of qualified epochs. | 10 to 15 minutes per patient (once) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, remote monitoring, COVID-19