NCT03448861

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

February 14, 2018

Last Update Submit

April 22, 2018

Conditions

Clinical Assessment

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Polso Wearable watch

EXPERIMENTAL

Polso Wearable watch for the purpose of NEWS measurement

Device: Polso Wearebale watch

Interventions

Polso Wearebale watchDEVICE

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.

Polso Wearable watch

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Male or female, aged 18 years or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Van Velthoven MH, Adjei F, Vavoulis D, Wells G, Brindley D, Kardos A. ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients-protocol and study design. BMJ Open. 2019 Sep 20;9(9):e028219. doi: 10.1136/bmjopen-2018-028219.

    PMID: 31542738DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 28, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

November 1, 2019

Last Updated

April 24, 2018

Record last verified: 2018-04