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NCT Number: NCT05321459

Predictive Outcome in Comatose Patients

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.

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Key information

Conditions

Coma Cardiopulmonary Resuscitation Cardiovascular Diseases Consciousness Disorders Heart Arrest Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHP Avicenne Hospital - Réanimation médico-chirurgicale, Bobigny, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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-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).

Exclusion criteria

  • Decision to limit resuscitation therapies taken by the resuscitation team
  • Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
  • Opposition by the trusted person or by the patient once he/she wakes up

Treatment and study plan

Neurological prognosis

Other

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.

Primary outcomes

  1. Awakening within 3 months

    Time frame: within 3 months ± 2 weeks after inclusion

    Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.

Secondary outcomes

  1. CPC score within 3 months

    Time frame: 3 months ± 2 weeks after inclusion

    CPC (Cerebral Performance Category) score is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.

    Range of values rates neurological status after cardiac arrest on a scale of 1 to 5 (1 for good cerebral performance up to 5 for brain death).

  2. mRS score within 3 months

    Time frame: 3 months ± 2 weeks after inclusion

    mRS (Modified Rankin Scale) scores is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.

    mRS (modified Rankin Scale) scale measures degree of disability/dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score can be between 0 (no symptoms at all) and 5 (major disability : bedridden, incontinent and requiring constant nursing care and attention).

  3. FOUR score within 3 months

    Time frame: 3 months ± 2 weeks after inclusion

    FOUR (Full Outline of UnResponsiveness) score is performed only if patient is still hospitalized (being awake or not).

    FOUR score is a grading scale for assessing the level of consciousness performed on patients with severe neurologic impairment..It addresses four domains of neurological functioning: Eye response; Motor response ; Brainstem score and Respiratory score.

    Score is ranging from 0 to 16 where the lower the score, the greater the coma gravity.

  4. GOSE score within 3 months

    Time frame: 3 months ± 2 weeks after inclusion

    GOSE (Extended Glasgow Outcome Scale) score is performed wether patient is still hospitalized or returned home.

    GOSE score classifies global outcomes in traumatic brain injury survivors. It rates patient status into one of eight categories ranging from 8 (Upper good recovery) to 1 (Dead).

  5. CPC score within 6 months

    Time frame: 6 months ± 2 weeks after inclusion

    CPC (Cerebral Performance Category) score is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.

    Range of values rates neurological status after cardiac arrest on a scale of 1 to 5 (1 for good cerebral performance up to 5 for brain death).

  6. mRS score within 6 months

    Time frame: within 6 months ± 2 weeks after inclusion

    mRS (Modified Rankin Scale) scores is performed wether patient is still hospitalized or returned home. It is performed by phone call if patient returned home.

    mRS (modified Rankin Scale) scale measures degree of disability/dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score can be between 0 (no symptoms at all) and 5 (major disability : bedridden, incontinent and requiring constant nursing care and attention).

  7. GOSE score within 6 months

    Time frame: within 6 months ± 2 weeks after inclusion

    GOSE (Extended Glasgow Outcome Scale) score is performed wether patient is still hospitalized or returned home.

    GOSE score classifies global outcomes in traumatic brain injury survivors. It rates patient status into one of eight categories ranging from 8 (Upper good recovery) to 1 (Dead).

  8. Awakening within 6 months ± 2 weeks

    Time frame: within 6 months ± 2 weeks after inclusion

    Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated. The measurement takes place only if patient is still hospitalized.

  9. CRS-R score within 6 months

    Time frame: within 6 months ± 2 weeks after inclusion

    CRS-R (Coma Recovery Scale - Revised) is a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intented to be used to establish diagnosis, monitor behavioral recovery and predict outcome. It is performed only if patient is still hospitalized.

    The total score ranges between 0 (worst) and 23 (best).

  10. PRECOM tool - first week of coma

    Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)

    Comparison of the ability of the PRECOM tool using clinical and electrophysiological data at inclusion (the first week of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).

  11. PRECOM tool - second week of coma

    Time frame: One week visit (one week after inclusion visit +/- 2 days)

    Comparison of the ability of the PRECOM tool using clinical and electrophysiological data the second week of coma, to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).

  12. PRECOM tool - first and second week of coma

    Time frame: Inclusion and one week visits

    Comparison of the ability of the PRECOM tool using combinaison of clinical and electrophysiological data collected both at inclusion and one week later (the first two weeks of coma), to classify patients with good prognosis, poor prognosis and indeterminate prognosis with respect to this same categorization using the usual evaluation criteria performed routinely by participating resuscitations (clinical examination and EEG for all and evoked potentials in addition for some).

  13. Awakening - second week of coma

    Time frame: One week visit (one week after inclusion visit +/- 2 days)

    Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.

  14. NSE blood marker

    Time frame: 3 days post cardiac arrest

    Comparison of the ability to predict awakening with the PRECOM tool using the NSE blood marker (neuron- spécific enolase) collected 3 days after cardiac arrest between the patients awakened from the coma and those who are not.

  15. Glial blood markor

    Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)

    Comparison of the ability to predict awakening with the PRECOM tool using the Glial Fibrillary Acidic Protein (GFAP) collected at the inclusion visit between the patients awakened from the coma and those who are not.

  16. Neuronal blood markor

    Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)

    Comparison of the ability to predict awakening with the PRECOM tool using the Neurofilament blood marker collected at the inclusion visit between the patients awakened from the coma and those who are not.

  17. Inflammatory blood markor

    Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)

    Comparison of the ability to predict awakening with the PRECOM tool using the inflammatory blood markers : Kynurenine and Tryptophan; collected at the inclusion visit between the patients awakened from the coma and those who are not.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie KUBIS, Md, PhD

CONTACT

[email protected]

+33(0)149958324

Romain SONNEVILLE, Md, PhD

CONTACT

[email protected]

+33(0)140256139

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ecole Normale Supérieure de Paris

Registry information

Official study title

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

Acronym: PRECOM

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 11, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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