CHroniSense National Early Warning Score Study

Study Overview
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Brief Summary
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ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals. The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart.

Detailed Description
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ChroniSense Medical Ltd. is developing a wearable medical multi-parametric monitoring system, Polso™. Polso™ provides a number of the parameters employed in various Early Warning Scores (EWS), such as the National Early Warning Score (NEWS), utilised widely in UK hospitals. The EWS is a physiological track and trigger system that is generated from multi- parameter or aggregate of vital signs measurements for early recognition of clinical deterioration in acutely admitted patients. Patients who are admitted into hospital are monitored with routinely measurements of these parameters that are manually recorded on a clinical chart. The parameters of the NEWS include: 1) respiratory rate pulse rate, 2) oxygen saturations, 3) body temperature; 4) systolic blood pressure, 5) heart rate, and 6) level of consciousness. Polso™ acquires, derives, and processes a number of physiological parameters. While ECG is not currently employed in NEWS, other parameters which are used in NEWS are available in the Polso™ system. In cases where manual testing is preferred for any parameter, such as use of supplemental oxygen, the individual score can be entered into the system manually. Polso™, as a wrist-based device, could enable a degree of flexibility in patient care and management. The goal of this study is to evaluate the suitability of Polso™ as a data acquisition and processing platform capable of providing EWS summaries, against the currently employed NEWS system at the Milton Keynes University Hospital (MKUH) Cardiology Unit. The Polso™ will be employed strictly as a data-gathering system, and will not be used to influence any clinical decisions; the standard NEWS as currently employed will fulfill all its normal clinical roles.

Official Title
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CHroniSense National Early Warning Score Study

Conditions
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Clinical Assessment

Intervention / Treatment
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* Device: Polso Wearebale watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study Male or female, aged 18 years or above Exclusion Criteria: Unable or unwilling to give valid consent for participation in the study Known history of allergy to nylon Current diagnosis of sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy and trigeminy) Weak pulse Patients with infectious diseases requiring isolation such as Methicillin Resistant Staphylococcus Aureus (MRSA), Clostridium difficile and Extended Spectrum Beta-Lactamases (ESBL) Patients with implantable defibrillators, pacemakers or neurostimulators Patients with Parkinson disease or essential tremor Patients with poor Llead I ECG signal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polso Wearable watch<br>Polso Wearable watch for the purpose of NEWS measurement | Device: Polso Wearebale watch<br>* The objective of the Polso™ feasibility study is to demonstrate the suitability of Polso™ as a data acquisition and processing platform by comparison with the conventional British version of EWS (UK-NEWS) on aggregate and on each individual parameter score. Although in a full NEWS system, the frequency of testing is determined by the score itself, this aspect will not be evaluated, in the event that a divergence of scores would complicate clinical evaluation and correspondence of readings. In addition, good clinical practice calls for patient care to be fully motivated by the NEWS currently in use, as opposed to the experimental Polso™. Therefore, this compromise will be made, which will still permits system evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | millimeters of mercury obtained by the Polso™ | Through study completion, an average of 1 year | 
| pulse rate | bpm obtained by the Polso™ | Through study completion, an average of 1 year | 
| respiratory rate | number of breaths per minute obtained by the Polso™ | Through study completion, an average of 1 year | 
| oxygen saturation | percent obtained by the Polso™ | Through study completion, an average of 1 year | 
| body temperature | Celsius temperature scale obtained by the Polso™ | Through study completion, an average of 1 year |