Predictive Outcome in Comatose Patients

Last updated: April 1, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Neurological prognosis

Clinical Study ID

NCT05321459
AOR 20045
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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-hospitalcardiac arrest (CA) with shockable or non-shockable rhythm

  • Persistent coma on day 3 after post CA, defined by the inability to respond to averbal command in an appropriate manner (motor Glasgow components ≤ 3) and at thetime of neurophysiological recordings (D3-D7 ± week -end).

Exclusion

Exclusion Criteria:

  • Decision to limit resuscitation therapies taken by the resuscitation team

  • Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion orany condition preventing to record AEP).

  • Opposition by the trusted person or by the patient once he/she wakes up

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Neurological prognosis
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
May 29, 2026

Study Description

Evaluating the prognosis of comatose participants after cardiac arrest (CA) in the intensive care unit remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations: 1 / the electroencephalogram, bad prognosis assessed when the electroencephalogram (EEG) is discontinuous, areactive, monotone,...), 2 / somesthetic evoked potentials, the absence of the N20 cortical wave has a specificity of poor prognosis of 68-100% and 3 / auditory evoked potentials (AEP), the presence of mismatchnegativity (MMN) would be of good prognosis with a specificity up to 90% but rarely performed in current practice. Routinely, these examinations are sometimes difficult to interpret in sedated participants, in an intensive care unit environment that generates numerous artefacts. Above all, all these techniques require the presence of a neurophysiology unit, with few experts available.

In a preliminary study, in collaboration with the applied mathematics laboratory of the ENS (Ecole Normale Supérieure), an algorithm was developed from the signal extracted from AEP. A probability map was generated with a software allowing to visually classify the participants after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". Neither artifacts or sedation prevented data analysis.

The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of participants admitted to intensive care for coma in the aftermath of a caridiac arrest will predict the neurological prognosis of participants with high sensitivity and specificity. This tool, carried out during the first week of the coma, will be compared to a standardized procedure used routinely by the participating resuscitators.

Connect with a study center

  • APHP Avicenne Hospital - Réanimation médico-chirurgicale

    Bobigny, 93000
    France

    Active - Recruiting

  • APHP Bichat Hospital -Médecine intensive - réanimation infectieuse

    Paris, 75018
    France

    Active - Recruiting

  • APHP Cochin Hospital - médecine intensive-réanimation

    Paris, 75014
    France

    Active - Recruiting

  • APHP HEGP hospital - Réanimation médicale

    Paris, 75015
    France

    Active - Recruiting

  • APHP Lariboisière Hospital, Clinical Physiology Department

    Paris, 75010
    France

    Site Not Available

  • APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique

    Paris, 75010
    France

    Active - Recruiting

  • Delafontaine Hospital - médecine intensive-réanimation

    Saint-Denis, 93200
    France

    Active - Recruiting

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