Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Sponsor

Stéphane Cook, Prof (Other)

Overall Status

Completed

CT.gov ID

NCT04379986

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

35.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Device: Senbiosys	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

May 31, 2020

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standardized measures in the cardiac catheterization laborator 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 The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
Experimental: Standardized measures in the intensive care unit 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 The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.

Arm

Intervention/Treatment

Experimental: Standardized measures in the cardiac catheterization laborator

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

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

Experimental: Standardized measures in the intensive care unit

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University and hospital Fribourg	Fribourg		Switzerland	1700

Sponsors and Collaborators

Stéphane Cook, Prof

Investigators

Study Chair: Stéphane Cook, MD, University of Freiburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stéphane Cook, Prof, Clinical Professor, University of Freiburg

ClinicalTrials.gov Identifier:

NCT04379986

Other Study ID Numbers:

SENBIOSYS trial

First Posted:

May 8, 2020

Last Update Posted:

Oct 20, 2021

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stéphane Cook, Prof, Clinical Professor, University of Freiburg

blood pressure

remote monitoring

COVID-19

Study Results

No Results Posted as of Oct 20, 2021