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| ID | Type | Description | Link |
|---|---|---|---|
| N° ID-RCB : 2024-A01607-40 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
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The detection and appropriate treatment of seizures significantly impact the neurological prognosis of patients in intensive care. Indeed, altered brain function including seizures is described in critically ill children, regardless of the reason for admission. Most seizures are subclinical and therefore impossible to diagnose without neuromonitoring tools. Despite being concidered ad Gold Standard, continuous EEG (cEEG) with video recording shows difficulty of implementation and interpretation at all hours of the day and night explaining that less than 10% of centers in France use cEEG routinely. Most departments prefer simplified techniques, including amplitude traces (aEEG) which can be used continuously at the bedside. However, the positive predictive value of aEEG in the detection of seizures does not exceed 78% and 64% in newborns and children respectively making necessary an optimization of the information provided by these techniques.
This project is a pragmatic diagnostic study that aims at developing and evaluating a neuromonitoring interface adapted to the needs of pediatric and neonatal intensive care units and meeting the requirements of neurophysiologists in terms of EEG trace quality.
This research will take place in three phases :
Post-hoc review of the entire EEG trace by an expert in pediatric EEG, blinded to the interpretation made at the bedside (gold standard).
Research hypothesis is that continuous neuromonitoring combining optimized quantitative EEG techniques and targeted advice from a neurophysiologist would allow the detection of a majority of seizure events requiring treatment and background trace abnormalities associated with critical encephalopathy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromonitoring with 10 electrodes | Other | In case of no parental objection, the clinician may begin neuromonitoring according to standard indications. The number of electrodes applied to the child's skull will be 10 electrodes (8 recording electrodes, 1 reference electrode, and 1 ground electrode) instead of the current 5. The intensivist will analyze the quantitative EEG trace as they currently do but will also have access to additional tools for seizure detection support (CDSA and seizure detection software) and targeted review of part of the recording by a neurophysiologist in case of doubt. Access to the neurophysiologist will be available during current working hours on weekdays. Data will be collected in 12-hour periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the diagnostic performance of neuromonitoring combining quantitative EEG and possible interpretation by a neurophysiologist in detecting neurological impairment. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the detection of convulsive seizures | 48 hours | |
| Evaluation of the classification of the background tracing in critical encephalopathy grade | 48 hours | |
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Inclusion Criteria :
Exclusion Criteria :
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Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noura ZAYAT, PH | Contact | 33 2 76 64 37 91 | noura.zayat@chu-nantes.fr | |
| Pierre BOURGOIN, PH | Contact | 33 2 76 64 36 12 | pierre.bourgoin@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
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| Impact of tracing aids on intensivists' confidence level during decision-making |
| 48 hours |
| Number of suitable anticonvulsant treatments | 48 hours |
| Prescription period for anticonvulsant treatments | 48 hours |
| Hypothermia treatment rates indicated after subsequent rereading of the tracing by the expert | 48 hours |