The New Golden Standard: the Early Warning Score Algorithm (EAGLE)

May 14, 2020 updated by: Patrizio Lancellotti, University of Liege
The objective is this study is the development and implementation of a smart algorithm to compute an early warning indicator able to predict early patient deterioration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data will be collected at the three sites using the SomnoTouchTM and MOXTM devices, commercially available and CE approved. Every month, the data will be sent to the KUL and UM to develop the algorithm. Study centers will also send some pre-defined patient characteristics extracted from the patient's EMR to better contextualize the data.

The EWS formula has a free interpretation of the vital parameters weighting and the vital parameters to be taken into account in the scoring system. Therefore, many variants of the EWS arose the past decade (i.e. MEWS, NEWS). The algorithm developed in this study should define an objective approach for the EWS formula, diminishing the discordances regarding the weight per parameter. Using a patient-personalized approach, the definite algorithm should be based on the patient's vital parameter measured during his/her whole hospitalization, generating a patient-personalized weight per parameter and an overall reliable EWS scoring system.

The EWS score is often only measured twice per day per patient, creating a large window for disease worsening. The algorithm developed in this study could be deployed along the wearable device developed in the WearIT4Health project. The device would continuously feed the algorithm with data acquired from its sensors. Thus, the EWS would be computed every 10 seconds.

The EWS scoring system has already been proven to be an effective approach in reducing clinical deterioration, reducing the admission to intensive care units and thus overall reducing mortality. However, as mentioned above the EWS is measured in a rather low frequency. Therefore, estimation of the EWS score via continuous monitored parameters should further increase patient survival.

The primary objective of the EAGLE study is to collect continuously monitored vital and activity parameter data and use it to develop an algorithm that can early identify clinical deterioration to optimize the application of the EWS system.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège
    • Limbourg
      • Genk, Limbourg, Belgium, 3600
        • Ziekenhuis Oost-Limburg
  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center+

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized for at least 1 day at the participating hospitals excluding patients admitted at high intensity units: Intensive care units, Coronary care units, Emergency room.

Description

Exclusion Criteria:

  • Suffering from infectious disease
  • Participating to another study that could intervene with the study results (e.g. experimental medication that could affect the heart rate).

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main Group
Hospitalized for at least 1 day clinic stay at the participating hospitals
Device: SomnoTouch

The patient will be equipped with the SomnoTouch device. This device is able to record and estimate the following data:

ECG data PPG data Heart rate Respiration rate Blood pressure (mmHg) Oxygen saturation (%).

All patient will be stored for further analysis.

Device: MOX

The patient will be equipped with the MOX device. This device is able to record and estimate the following data:

Accelerometers data Activity Body posture

All patient will be stored for further analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision of predictive early warning score algorithm
Time Frame: Up to 1 week
Precision defined of truepositives divided by the sum of truepositives and truenegatives. This measure indicates how often the predictive EWS was right in identifying adverse events.
Up to 1 week

Collaborators and Investigators

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

Sponsor

University of Liege

Collaborators

KU Leuven
Hasselt University
Ziekenhuis Oost-Limburg
Maastricht University
Academisch Ziekenhuis Maastricht

Investigators

  • Principal Investigator: Patrizio Lancellotti, Liège University Hospital - CHU de Liège
  • Study Director: Pierre Delanaye, Liège University Hospital - CHU de Liège
  • Study Director: Arnaud Ancion, Liège University Hospital - CHU de Liège
  • Study Director: Pieter Vandervoort, Department of Cardiology and Department Future Health, Ziekenhuis Oost-Limburg
  • Study Chair: Dianne de Korte-de Boer, Maastricht University Medical Centre, department of Anesthesiology

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 (Actual)

April 1, 2019

Primary Completion (Actual)

November 4, 2019

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/184

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.

Clinical Trials on Early Warning Score

Clinical Trials on SomnoTouch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe