Actively Recruiting
Predictive Outcome in Comatose Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-12-23
100
Participants Needed
7
Research Sites
236 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
E
Ecole Normale Supérieure de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predictive Outcome in Comatose Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18 years old
- Patient affiliated to a French Health 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 appropriately (motor Glasgow components 3) and at the time of neurophysiological recordings (D3-D7 1 week-end)
You will not qualify if you...
- Decision to limit resuscitation therapies taken by the resuscitation team
- Inability to perform the auditory evoked potentials (AEP) due to deafness, skin lesion or any other condition preventing AEP recording
- Opposition by the trusted person or by the patient once he/she wakes up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, France, 93000
Actively Recruiting
2
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, France, 75010
Active, Not Recruiting
3
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, France, 75010
Actively Recruiting
4
APHP Cochin Hospital - médecine intensive-réanimation
Paris, France, 75014
Actively Recruiting
5
APHP HEGP hospital - Réanimation médicale
Paris, France, 75015
Actively Recruiting
6
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
Paris, France, 75018
Actively Recruiting
7
Delafontaine Hospital - médecine intensive-réanimation
Saint-Denis, France, 93200
Actively Recruiting
Research Team
N
Nathalie KUBIS, Md, PhD
CONTACT
R
Romain SONNEVILLE, Md, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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