Rationale and Design of the BECA Project: Smartwatch-based Activation of the Chain of Survival for Out-of-Hospital Cardiac Arrest

ABSTRACT

Introduction Out-of-hospital cardiac arrest (OHCA) is a major health problem, and the overall survival rate is low (4.6%-16.4%). The initiation of the current chain of survival depends on the presence of a witness of the OHCA, which is not present in 29.7%-63.4% of the cases. Furthermore, a delay in starting this chain is common in witnessed OHCA. This project aims to reduce morbidity and mortality due to OHCA by developing a smartwatch-based solution to expedite the chain of survival in the case of (un)witnessed OHCA.

Methods and analysis Within the BECA (BEating Cardiac Arrest) project, we aim to develop a demonstrator product that can detect OHCA using photoplethysmography and accelerometer analysis, and autonomously alert emergency medical services. A target group study will be performed to determine who benefits the most from this product. Furthermore, several clinical studies will be conducted to capture or simulate data on OHCA cases, as to develop detection algorithms and validate their diagnostic performance. Volunteers will be asked to simulate OHCA by interrupting radial arterial and venous blood flow by blood pressure cuff inflation while lying still. Data will also be captured during cardiac electrophysiologic and implantable cardioverter defibrillator (ICD) testing procedures. In addition, patients at risk for OHCA are recruited to acquire measurements over a longer period. Moreover, studies on psychosocial and ethical acceptability will be conducted, consisting of surveys, focus groups, and interviews. These studies will focus on end-user preferences and needs, to ensure that important individual and societal values are respected in the design process.

Ethics and dissemination Ethical approval or waivers will be sought from the research ethics committees of the different institutions. Written informed consent will be obtained from the participants of all studies. Study findings will be submitted to international peer-reviewed journals and will be presented at international scientific conferences.

Strengths

- This research project aims to develop unobtrusive technology that could save lives by autonomously alerting emergency medical services in case of out-of-hospital cardiac arrest.

- The project includes a broad range of aspects to maximize the technology’s chance of adoption: clinical, technical, psychological, and ethical.

- The project aims for the inclusion of a wide and diverse research sample and the involvement of different stakeholder groups to minimize bias and ensure accessibility for everyone in society.

Competing Interest Statement

Contracts have been granted by Medtronic B.V. to the institution of Lukas R.C. Dekker. Reinder Haakma is currently employed by Philips Electronics Nederland B.V. Tom A. Kooy is currently employed by Stan B.V. Carlijn A. Vernooij has been employed by Philips Electronics Nederland B.V. Rik Vullings has been a consultant for Philips Electronics Nederland B.V. Both Philips Electronics Nederland B.V. and Stan B.V. are involved with the BECA project.

Funding Statement

This research project is financed by the PPP Allowance made available by Top Sector Life Sciences & Health to the Dutch Heart Foundation to stimulate public-private partnerships, grant number 01-003-2021-B005, and by Philips Electronics Nederland B.V. Hanno L. Tan has received funding from the European Union COST Action PARQ (grant agreement No CA19137) supported by COST (European Cooperation in Science and Technology).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

There are no data produced in the present work.

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