Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence (PREDICT-CE) (PREDICT-CE)

Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence

The investigators wish to build up a database of clinical data and physiological signals with a view to developing a predictive algorithm based on continuous analysis of the intracranial pressure waveform and other parameters commonly used in intensive care to predict the occurrence of an episode of intracranial hypertension (HTIC). This algorithm will be designed using supervised learning statistical methods based on innovative statistical analysis methods (artificial intelligence). These methods are classically used to exploit massive data such as sensor data.

Study Overview

• Status: Recruiting
• Conditions: Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Olivier HUET; Phone Number: +33 0298347288; Email: olivier.huet@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU de Brest
    • Contact: Olivier Huet; Phone Number: 0298347288; Email: olivier.huet@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any neuro-injured patient admitted to intensive care

Description

Inclusion Criteria:

• More than 18 years
• admission to intensive care for less than 3 days for a neurological lesion
• Sensor placement for intracranial pressure monitoring

Exclusion Criteria:

• patient under judicial protection
• refusal to participate
• patients under 18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of a database of clinical data and physiological signals to develop a predictive algorithm based on continuous analysis of the intracranial pressure waveform to predict the occurrence of an episode of intracranial hypertension.	Occurrence of an episode of intracranial hypertension defined as ICP >20mmHg for 30 minutes	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predict long-term functional outcome using intracranial pressure wave signal modeling and other parameters collected in real time	Occurrence of vasospasm diagnosed by cerebral perfusion angioscanner	28 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension
• Other Study ID Numbers: 29BRC20.0293 - PREDICT-CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three month and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No