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Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379986
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Stéphane Cook, Prof, University of Freiburg

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379986


Locations
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Switzerland
University and hospital Fribourg
Fribourg, Switzerland, 1700
Sponsors and Collaborators
Stéphane Cook, Prof
Investigators
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Study Chair: Stéphane Cook, MD University of Freiburg
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stéphane Cook, Prof, University of Freiburg:
blood pressure
remote monitoring
COVID-19