Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-11-15
2028-05-29
Brief Summary
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The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Detailed Description
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In a preliminary study, in collaboration with the applied mathematics laboratory of the ENS (Ecole Normale Supérieure), an algorithm was developed from the signal extracted from AEP. A probability map was generated with a software allowing to visually classify the participants after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". Neither artifacts or sedation prevented data analysis.
The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of participants admitted to intensive care for coma in the aftermath of a caridiac arrest will predict the neurological prognosis of participants with high sensitivity and specificity. This tool, carried out during the first week of the coma, will be compared to a standardized procedure used routinely by the participating resuscitators.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Comatose patients in intensive care unit
Patient admitted in the intensive care unit (ICU) for post cardiac arrest (CA) coma, persistent for at least 3 days after CA.
Neurological prognosis
In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP).
An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis".
The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.
Interventions
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Neurological prognosis
In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP).
An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis".
The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.
Eligibility Criteria
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Inclusion Criteria
* Patient affiliated to a French Heath Care Insurance
* Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm
* Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).
Exclusion Criteria
* Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
* Opposition by the trusted person or by the patient once he/she wakes up
18 Years
ALL
No
Sponsors
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Ecole Normale Supérieure de Paris
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Nathalie KUBIS, Md,PhD
Role: STUDY_DIRECTOR
APHP Lariboisière Hospital, Clinical Physiology Department
Locations
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APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, , France
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, , France
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, , France
APHP Cochin Hospital - médecine intensive-réanimation
Paris, , France
APHP HEGP hospital - Réanimation médicale
Paris, , France
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
Paris, , France
Delafontaine Hospital - médecine intensive-réanimation
Saint-Denis, , France
Countries
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Central Contacts
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Facility Contacts
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Johanna OZIEL, Ph
Role: primary
Bruno MEGARBANE, MD, PhD
Role: primary
Sarah BENGHANEM, Ph
Role: primary
Jean-Luc DIEHL, Md,PhD
Role: primary
Marc DOMAN, Ph
Role: primary
Daniel DA SILVA, Md
Role: primary
Other Identifiers
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AOR 20045
Identifier Type: -
Identifier Source: org_study_id