Blood Pressure
Conditions
Keywords
blood pressure, remote monitoring, COVID-19
Brief summary
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
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.
Interventions
DEVICESenbiosys
The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
Sponsors
Stéphane Cook, Prof
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of non-invasive BP monitors: blood pressure | 10 to 15 minutes per patient (once) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of signal with artefact, | 10 to 15 minutes per patient (once) | Secondary outcomes include reliability index (Qualification Index QI) for blood pressure epochs and count of qualified epochs. |
Countries
Switzerland
Outcome results
None listed