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

Recruiting

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

• Registration Number: NCT06555900
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-17
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	30 minutes	Occurrence of an episode of intracranial hypertension defined as ICP \>20mmHg for 30 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France