Predictive Outcome in Comatose Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Neurological prognosis
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Ecole Normale Supérieure de Paris
Collaborator
Source ClinicalTrials.gov