Informations générales (source: ClinicalTrials.gov)
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2023
mai 2026
08 septembre 2025
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive
care unit (ICU) remains challenging. It requires a multimodal approach combining
standardized clinical examination, serum biomarkers, imaging and classically
electrophysiological examinations, (among them auditive evoked potentials or AEP) but
none has a sufficient sensitivity/specificity. In a preliminary study, the investigators
developed an algorithm from the signal collected with AEP, and generated a probability
map to visually classify the participants after the algorithm processing. Participants
could be classified either with a good neurological prognosis or with bad neurological
prognosis or death.
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE ST-DENIS | KUBIS Nathalie | 18/09/2025 17:32:12 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:32:13 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP HEGP hospital - Réanimation médicale - 75015 - Paris - France | Jean-Luc DIEHL, Md,PhD | Contact (sur clinicalTrials) | |||
| APHP Lariboisière Hospital, Clinical Physiology Department - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique - 75010 - Paris - France | Bruno MEGARBANE, MD, PhD | Contact (sur clinicalTrials) | |||
| Delafontaine Hospital - médecine intensive-réanimation - 93200 - Saint-Denis - France | Daniel DA SILVA, Md | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age above18 years old
- 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).
- Age above18 years old
- 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).
- Decision to limit resuscitation therapies taken by the resuscitation team
- 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