NCT04292158

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
2 countries

3 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

October 1, 2019

Last Update Submit

May 14, 2020

Conditions

Early Warning Score

Keywords

Early warning scoreVital parametersPredictive algorithmMedical Devices

Outcome Measures

Primary Outcomes (1)

  • Precision of predictive early warning score algorithm

    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

Study Arms (1)

Main Group

Hospitalized for at least 1 day clinic stay at the participating hospitals

Device: SomnoTouchDevice: MOX

Interventions

SomnoTouchDEVICE

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.

Main Group
MOXDEVICE

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.

Main Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ziekenhuis Oost-Limburg

Genk, Limbourg, 3600, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Maastricht University Medical Center+

Maastricht, Netherlands

Location

Related Publications (5)

  • Gerry S, Birks J, Bonnici T, Watkinson PJ, Kirtley S, Collins GS. Early warning scores for detecting deterioration in adult hospital patients: a systematic review protocol. BMJ Open. 2017 Dec 3;7(12):e019268. doi: 10.1136/bmjopen-2017-019268.

    PMID: 29203508BACKGROUND

  • Jarvis S, Kovacs C, Briggs J, Meredith P, Schmidt PE, Featherstone PI, Prytherch DR, Smith GB. Aggregate National Early Warning Score (NEWS) values are more important than high scores for a single vital signs parameter for discriminating the risk of adverse outcomes. Resuscitation. 2015 Feb;87:75-80. doi: 10.1016/j.resuscitation.2014.11.014. Epub 2014 Nov 26.

    PMID: 25433295BACKGROUND

  • Moon A, Cosgrove JF, Lea D, Fairs A, Cressey DM. An eight year audit before and after the introduction of modified early warning score (MEWS) charts, of patients admitted to a tertiary referral intensive care unit after CPR. Resuscitation. 2011 Feb;82(2):150-4. doi: 10.1016/j.resuscitation.2010.09.480. Epub 2010 Nov 5.

    PMID: 21056524BACKGROUND

  • Ajami S, Teimouri F. Features and application of wearable biosensors in medical care. J Res Med Sci. 2015 Dec;20(12):1208-15. doi: 10.4103/1735-1995.172991.

    PMID: 26958058BACKGROUND

  • Smith MEB, Chiovaro JC, O'Neil M, Kansagara D, Quinones A, Freeman M, Motu'apuaka M, Slatore CG. Early Warning System Scores: A Systematic Review [Internet]. Washington (DC): Department of Veterans Affairs (US); 2014 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK259026/

    PMID: 25506953BACKGROUND

Study Officials

  • Patrizio Lancellotti

    Liège University Hospital - CHU de Liège

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • Dianne de Korte-de Boer

    Maastricht University Medical Centre, department of Anesthesiology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2019

First Posted

March 2, 2020

Study Start

April 1, 2019

Primary Completion

November 4, 2019

Study Completion

April 30, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

BE(2)NL(1)