Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Blood Pressure Clinical Trial

Official title:

Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379986
• Other study ID #: SENBIOSYS trial
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2020
• Source: University of Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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

Locations

Country	Name	City	State
Switzerland	University and hospital Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
Stéphane Cook, Prof

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Martínez G, Howard N, Abbott D, Lim K, Ward R, Elgendi M. Can Photoplethysmography Replace Arterial Blood Pressure in the Assessment of Blood Pressure? J Clin Med. 2018 Sep 30;7(10). pii: E316. doi: 10.3390/jcm7100316. — View Citation

Smolle KH, Schmid M, Prettenthaler H, Weger C. The Accuracy of the CNAP® Device Compared with Invasive Radial Artery Measurements for Providing Continuous Noninvasive Arterial Blood Pressure Readings at a Medical Intensive Care Unit: A Method-Comparison S — View Citation

Watanabe N, Bando YK, Kawachi T, Yamakita H, Futatsuyama K, Honda Y, Yasui H, Nishimura K, Kamihara T, Okumura T, Ishii H, Kondo T, Murohara T. Development and Validation of a Novel Cuff-Less Blood Pressure Monitoring Device. JACC Basic Transl Sci. 2017 D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)