Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Not Applicable

Completed

• Conditions: Blood Pressure

• Registration Number: NCT04379986
• Lead Sponsor: Stéphane Cook, Prof

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.

Study Timeline

• Study First Submitted: 2020-04-22
• Status Verified: 2020-05
• Study Start: 2020-05-01
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-08
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University and hospital Fribourg; 🇨🇭 Fribourg, Switzerland