New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
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 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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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).

Locations
Other Locations
France
APHP Avicenne Hospital - Réanimation médico-chirurgicale
RECRUITING
Bobigny
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
RECRUITING
Paris
APHP Cochin Hospital - médecine intensive-réanimation
RECRUITING
Paris
APHP HEGP hospital - Réanimation médicale
RECRUITING
Paris
APHP Lariboisière Hospital, Clinical Physiology Department
ACTIVE_NOT_RECRUITING
Paris
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
RECRUITING
Paris
Delafontaine Hospital - médecine intensive-réanimation
RECRUITING
Saint-denis
Contact Information
Primary
Nathalie KUBIS, Md, PhD
nathalie.kubis@aphp.fr
+33(0)149958324
Backup
Romain SONNEVILLE, Md, PhD
romain.sonneville@aphp.fr
+33(0)140256139
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2026-05-29
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris
Collaborators: Ecole Normale Supérieure de Paris

This content was sourced from clinicaltrials.gov