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NCT Number: NCT06555900

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 30 minutes

    Occurrence of an episode of intracranial hypertension defined as ICP >20mmHg for 30 minutes

Secondary outcomes

  1. Predict long-term functional outcome using intracranial pressure wave signal modeling and other parameters collected in real time

    Time frame: 28 days

    Occurrence of vasospasm diagnosed by cerebral perfusion angioscanner

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier HUET

CONTACT

[email protected]

0298347288 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PREDICT-CE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.