ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design

Abstract

Introduction: The National Early Warning Score is used as standard clinical practice in the UK as a track and trigger system to monitor hospitalised patients. Currently, nurses are tasked to take routine vital signs measurements and manually record these on a clinical chart. Wearable devices could provide an easier, reliable, more convenient and cost-effective method of monitoring. Our aim is to evaluate the clinical validity of Polso (ChroniSense Medical, Yokneam Illit, Israel), a wrist-based device, to provide National Early Warning Scores.

Methods and analysis: We will compare Polso National Early Warning Score measurements to the currently used manual measurements in a UK Teaching District General Hospital. Patients aged 18 years or above who require recordings of observations of vital signs at least every 6 hours will be enrolled after consenting. The sample size for the study was calculated to be 300 participants based on the assumption that the final dataset will include four pairs of measurements per-patient and per-vital sign, resulting in a total of 1200 pairs of data points per vital sign. The primary outcome is the agreement on the individual parameter scores and values of the National Early Warning Score: (1) respiratory rate, (2) oxygen saturation, (3) body temperature, (4) systolic blood pressure and (5) heart rate. Secondary outcomes are the agreement on the aggregate National Early Warning Score. The incidence of adverse events will be recorded. The measurements by the device will not be used for the clinical decision-making in this study.

Ethics and dissemination: We obtained ethical approval, reference number 18/LO/0123 from London-Hampstead Research Ethics Committee, through the Integrated Research Application System, (reference number: 235 034. The study received no objection from the Medicine and Health Regulatory Authority, reference number: CI/20018/005 and has National Institute for Health Research portfolio adoption status CPMS number: 32 532.

Trial registration number: NCT03448861; Pre-results.

Keywords: Mobile Applications [MeSH]; digital health; early warning signs; health apps; medical device.

Conflict of interest statement

Competing interests: The research sponsor for this study is Milton Keynes University Hospital (MKUH) NHS Foundation Trust and collaborator is Oxford University NHS Foundation Trust. DB is a stockholder in Translation Ventures. (Charlbury, Oxfordshire, UK) and IP Asset Ventures (Oxford, Oxfordshire, UK), companies that, among other services, provide cell therapy biomanufacturing, regulatory and financial advice to pharmaceutical clients. DB is also subject to the CFA Institute’s codes, standards and guidelines, so, he must stress that this piece is provided for academic interest only and must not be construed in any way as an investment recommendation. Additionally, at the time of publication, DB and the organisations with which he is affiliated may or may not have agreed and/or have pending funding commitments from the organisations named here.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

National Early Warning System table: A, alert; BP, blood pressure; NEWS, National Early Warning Score; NHS, National Health Service; P, pain; U, Unresponsive; V, Verbal.

Figure 2

Adapted consort 2010 flow diagram. A, alert; P, pain; U, unresponsive; V, verbal

Figure 3

The POLSO system components.

Figure 4

Results of systolic pressure bootstrap simulation studies on healthy subject data (indicating optimal calibration/validation cohort breakdown).

Figure 5

Results of diastolic pressure bootstrap simulation studies on healthy subject data (indicating optimal calibration/validation cohort breakdown). MAE; mean absolute error.

Figure 6

The flow of participants through the study.