NCT04462380

Brief Summary

The overall incidence of cardiorespiratory arrest in Europe is estimated at 350,000 to 700,000 cases per year. Survival rate is estimated at 10.7% for all rhythm disorders combined. Several examples of AI application in the medical field exist. Ting et al have developed a computer tool capable of diagnosing the presence of diabetic retinopathy with excellent power. In resuscitation, Celi et al proposed a tool capable of predicting the need for crystalloid vascular filling during a systemic inflammatory state. In Nature in 2018, Komorowski demonstrated the efficacy of AI in the hemodynamic management of sepsis. In a study of the renal response to fluid challenge, Zhang et al. demonstrate the effectiveness of the learning machine. Objectives: Determination of an algorithm capable of predicting the mortality of patients admitted to intensive care units (ICU) for ACR from hospitalization reports (CRH). Also use of the algorithm to predict the risk of recurrence of the arrest, the duration of mechanical ventilation, the appearance of sepsis, the development of organ failure, prediction of the CPC (Cerebral Performance Category), time to obtain catecholamine withdrawal, the appearance of acute renal failure with or without the need for extra-renal purification (EER) and duration under EER, the average length of stay. This project is part of a larger, nationwide project with greater power, and includes all the data generated during hospitalization in intensive care. Method: an estimated total number of patients included in this study to be between 300 and 500. The population will come from the intensive care units of Nice, Antibes, Cannes, Grasse. Inclusion will be retrospective, on CRH, CR of CT imaging (cerebral and thoraco-abdomino-pelvic), MRI, EEG, and daily follow-up words, from 2014 to the end of 2020. After anonymisation, application of semantisation using natural language processing (NLP) methods. The data to be extracted are entered in a document written by intensive care physicians. These data will then be stored in a database. In order to meet the main objective, we will develop a computer algorithm capable of predicting mortality in the study population. This algorithm, based on a large database, can be designed using machine learning or even deep learning techniques depending on the amount of data to be processed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

July 3, 2020

Last Update Submit

July 3, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Prediction of mortality in the intensive care unit

    Definition of a semantic reporting tool, automated, transition from an anonymized report to an operational and relevant database.

    1day

  • Prediction of mortality in the intensive care unit

    Use of the database thus created to create an intelligent mortality prediction algorithm. Use also on secondary judgment criteria in order to predict other parameters mentioned below.

    1day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ACR for all causes, admitted in intensive care or intensive care, from the hospital centres of Nice, Antibes, Cannes, Grasse, etc.

You may qualify if:

  • OCA recovered from: hypoxic, ischemic, pulmonary embolism, tamponade, rhythm or conduction disorder, shockable or not, intra or extra-hospital.
  • CR computerized, typed in PDF format

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice Hospital

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

romain LOMBARDI

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 8, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations