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RecruitingNCT06555900PREDICT-CEUpdated Aug 15, 2024

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

An observational study in Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside, sponsored by University Hospital, Brest. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by University Hospital, Brest · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Dec 2020; still recruiting 5 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
500
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

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

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's planned enrollment of 500 is above the median of 60 across 80 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any neuro-injured patient admitted to intensive care

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No
06

What researchers measure

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.

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

    Time frame: 30 minutes

Secondary outcomes

  1. 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

    Time frame: 28 days

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06555900
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Aug 15, 2024
Start date
Dec 17, 2020
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Aug 15, 2024

Study contacts

Olivier HUET
Contact
olivier.huet@chu-brest.fr
0298347288 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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