Clinical trial NCT04379986: Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device
Official title: Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: blood pressure
remote monitoring
COVID-19
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Feasibility of non-invasive BP monitors: blood pressure
timeFrame: 10 to 15 minutes per patient (once)
Secondary outcomes:
measure: Percentage of signal with artefact,
timeFrame: 10 to 15 minutes per patient (once)
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: University and hospital Fribourg
Study officials:
affiliation: University of Freiburg
name: Stéphane Cook, MD
role: STUDY_CHAIR
References:
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 Dec 25;2(6):631-642. doi: 10.1016/j.jacbts.2017.07.015. eCollection 2017 Dec.
citation: 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.
citation: 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.
citation: 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.