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RECRUITING
NCT05321459

Predictive Outcome in Comatose Patients

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-11-15

Completion Date

2028-05-29

Last Updated

2025-12-23

Healthy Volunteers

Not specified

Interventions

OTHER

Neurological prognosis

In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP). An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.

Locations (7)

APHP Avicenne Hospital - Réanimation médico-chirurgicale

Bobigny, France

APHP Lariboisière Hospital, Clinical Physiology Department

Paris, France

APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique

Paris, France

APHP Cochin Hospital - médecine intensive-réanimation

Paris, France

APHP HEGP hospital - Réanimation médicale

Paris, France

APHP Bichat Hospital -Médecine intensive - réanimation infectieuse

Paris, France

Delafontaine Hospital - médecine intensive-réanimation

Saint-Denis, France