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Recruiting NCT02893462

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

Observational Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Critical Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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;

Primary outcome measures

  • Number of participants with physiological signal abnormality [Time frame: from two to twenty-four hours]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHRU de Brest — Brest

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. PMID 35169170
  • 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. PMID 33886075
  • 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. PMID 30666472

Identifiers

NCT: NCT02893462 · REASTOC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗