Remote Blood Pressure Monitoring With the Wearable SENBIOSYS Photoplethysmographic Device

NCT04379986 | Completed DMC

• 1 other identifier: SENBIOSYS trial
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

blood pressure; remote monitoring; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of signal with artefact,

  10 to 15 minutes per patient (once)

Study Arms (2)

Standardized measures in the cardiac catheterization laborator

EXPERIMENTAL

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

Standardized measures in the intensive care unit

EXPERIMENTAL

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

Interventions

Senbiosys DEVICE

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

Standardized measures in the cardiac catheterization laborator; Standardized measures in the intensive care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients referred for coronarography

You may not qualify if:

• 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

Sponsors & Collaborators

• Stéphane Cook, Prof: lead

Study Sites (1)

University and hospital Fribourg

Fribourg, 1700, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 30062178 RESULT

• 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.

  PMID: 26496367 RESULT

• 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.

  PMID: 30274376 RESULT

• 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.

  PMID: 34617912 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stéphane Cook, MD

  University of Freiburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 8, 2020
• Study Start: May 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 20, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)