Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's BedsidePREDICT-CENCT06555900
Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence (PREDICT-CE)
An observational study of Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside, run by University Hospital, Brest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any neuro-injured patient admitted to intensive care
Who may be able to join
- More than 18 years
- admission to intensive care for less than 3 days for a neurological lesion
- Sensor placement for intracranial pressure monitoring
Who cannot join
- patient under judicial protection
- refusal to participate
- patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Olivier Huet, 0298347288, olivier.huet@chu-brest.fr
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start17 Dec 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's BedsideStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555900
- Sponsor's protocol ID
- 29BRC20.0293 - PREDICT-CE
- Acronym
- PREDICT-CE
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Episodes of Intracranial Hypertension in Neuro-injured Patients: Development of a Decision Algorithm Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06555900
- Acronym / sponsor ID
- PREDICT-CE / 29BRC20.0293 - PREDICT-CE
- Conditions
- Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any neuro-injured patient admitted to intensive care
Key inclusion criteria (3 listed)
- More than 18 years
- admission to intensive care for less than 3 days for a neurological lesion
- Sensor placement for intracranial pressure monitoring
Key exclusion criteria (3 listed)
- patient under judicial protection
- refusal to participate
- patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Predict long-term functional outcome using intracranial pressure wave signal modeling and other parameters collected in real time
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Creation of a Warehouse of Clinical Data and Physiological Signals at the Patient's Bedside, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HUET (0298347288 ext. +33, olivier.huet@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.