Predictive Outcome in Comatose Patients
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
| Condition(s) | Coma, Heart Arrest, Cardiopulmonary Resuscitation |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 mult |
| Who can participate | 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). Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Bobigny, France; Paris, France; Paris, France; Paris, France; Paris, France; Paris, France (+1 more sites) |
| Start date | 2023-11-15 |
| NCT ID | NCT05321459 |
| Official listing | https://clinicaltrials.gov/study/NCT05321459 |