CHroniSense National Early Warning Score Study (CHESS)

April 22, 2018 updated by: BlueWind Medical

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Polso Wearable watch
Polso Wearable watch for the purpose of NEWS measurement
Device: Polso Wearebale watch
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BlueWind Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (ACTUAL)

February 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 22, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CP- 090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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