Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care (REASTOC)

The aim of this study is the establishment of a warehouse physiological data and biomedical signal in intensive care adult patients in acute situations from particular records from the Philips Intellivue MP70 monitor.

Study Overview

• Status: Unknown
• Conditions: Critical Illness

Detailed Description

Cardiopulmonary failures are major public health concerns, due to the aging population. Each of these situations is burdened with a poor prognosis in the medium term and a source of prolonged hospitalizations, generating significant health costs. Early detection and prediction of organ failure could reduce health costs and risks for the patient, offering a reaction early and appropriate medical technology. The proposed approach aims to optimize the knowledge of a complex physiological domain and multi-system, while promoting the automatic transfer of knowledge. The approach proposed data-mining and development of algorithms for detecting and / or predicting a strong potential for disruption because it proposes to apply innovative automated analysis procedures to a fragile patient population, and then a transfer to the medical device industry.

From communicating tools of recording of the signals, the investigator envisage in a global way:

1. the constitution of a warehouse of physiological data of grown-up patients in acute situation (intensive care unit);
2. the development by data mining of a system of detection of organs failures or adverse events basing itself on the application of innovative algorithms, allowing the decision-making operational, from the fusion of arisen ill-assorted events;
3. the use of intelligent tools of auto-learning and elaboration of complex multimodal models for purposes of prediction of events;

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Erwan L'Her, Professor; Phone Number: 02 98 34 71 81; Email: erwan.lher@chu-brest.fr

Participation Criteria

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

Population of patients admitted in the intensive care unit for monitoring of vital failure

Description

Inclusion Criteria:

• Any adult patient admitted in Brest University Hospital's intensive care unit for monitoring of vital failure

Exclusion Criteria:

• Refusal to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with physiological signal abnormality	Whereas this is a data mining process (non-deterministic approach), no description can be provided	from two to twenty-four hours

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Erwan L'Her, Professor, CHRU de Brest

Publications and helpful links

General Publications

• Bodenes L, N'Guyen QT, Le Mao R, Ferriere N, Pateau V, Lellouche F, L'Her E. Early heart rate variability evaluation enables to predict ICU patients' outcome. Sci Rep. 2022 Feb 15;12(1):2498. doi: 10.1038/s41598-022-06301-9.
• L'Her E, Nazir S, Pateau V, Visvikis D. Accuracy of noncontact surface imaging for tidal volume and respiratory rate measurements in the ICU. J Clin Monit Comput. 2022 Jun;36(3):775-783. doi: 10.1007/s10877-021-00708-x. Epub 2021 Apr 22.
• L'Her E, N'Guyen QT, Pateau V, Bodenes L, Lellouche F. Photoplethysmographic determination of the respiratory rate in acutely ill patients: validation of a new algorithm and implementation into a biomedical device. Ann Intensive Care. 2019 Jan 21;9(1):11. doi: 10.1186/s13613-019-0485-z.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: data mining; data warehousing; data aggregation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: REASTOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Ananymized warehouse platform will be shared to other researchers all over the world