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Predictive Outcome in Comatose Patients

NCT05321459 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Coma
  • Heart Arrest
  • Cardiopulmonary Resuscitation

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.

Sponsors & Collaborators

  • Ecole Normale Supérieure de Paris

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nathalie KUBIS, Md,PhD · APHP Lariboisière Hospital, Clinical Physiology Department

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2028-03-01
Completion
2028-05-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05321459 on ClinicalTrials.gov