Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device
NCT ID: NCT04379986
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2020-05-01
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Senbiosys
The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
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.
Senbiosys
The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
Interventions
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Senbiosys
The patients will undergo blood pressure estimation as per clinical routine and will simultaneously wear the device.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Coronarography in patients with myocardial infarction
* Patient with suspected or certified COVID-infection
* Patients with atrial fibrillation
18 Years
ALL
Yes
Sponsors
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Stéphane Cook, Prof
OTHER
Responsible Party
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Stéphane Cook, Prof
Clinical Professor
Principal Investigators
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Stéphane Cook, MD
Role: STUDY_CHAIR
University of Freiburg
Locations
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University and hospital Fribourg
Fribourg, , Switzerland
Countries
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References
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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 Dec 25;2(6):631-642. doi: 10.1016/j.jacbts.2017.07.015. eCollection 2017 Dec.
Smolle KH, Schmid M, Prettenthaler H, Weger C. The Accuracy of the CNAP(R) Device Compared with Invasive Radial Artery Measurements for Providing Continuous Noninvasive Arterial Blood Pressure Readings at a Medical Intensive Care Unit: A Method-Comparison Study. Anesth Analg. 2015 Dec;121(6):1508-16. doi: 10.1213/ANE.0000000000000965.
Martinez 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):316. doi: 10.3390/jcm7100316.
Schukraft S, Boukhayma A, Cook S, Caizzone A. Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol for a Single-Center Prospective Clinical Trial. JMIR Res Protoc. 2021 Oct 7;10(10):e30051. doi: 10.2196/30051.
Other Identifiers
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SENBIOSYS trial
Identifier Type: -
Identifier Source: org_study_id