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OpenTrials
Completed

NCT Number: NCT04379986

Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

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.

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Key information

Conditions

Blood Pressure COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University and hospital Fribourg

Fribourg, 1700, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Senbiosys

Device

The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.

Primary outcomes

  1. Feasibility of non-invasive BP monitors: blood pressure

    Time frame: 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 outcomes

  1. Percentage of signal with artefact,

    Time frame: 10 to 15 minutes per patient (once)

    Secondary outcomes include reliability index (Qualification Index QI) for blood pressure epochs and count of qualified epochs.

Sponsors and collaborators

Lead sponsor

Stéphane Cook, Prof

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 8, 2020
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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