Predictive Outcome in Comatose Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neurological prognosis.
- Who it may be relevant to
- Registry conditions: Coma, Heart Arrest, Cardiopulmonary Resuscitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Overview
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.
Detailed 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.
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 algori
Primary outcome measures
- Awakening within 3 months [Time frame: within 3 months ± 2 weeks after inclusion]
Secondary outcome measures (12)
- CPC score within 3 months [Time frame: 3 months ± 2 weeks after inclusion]
- mRS score within 3 months [Time frame: 3 months ± 2 weeks after inclusion]
- FOUR score within 3 months [Time frame: 3 months ± 2 weeks after inclusion]
- GOSE score within 3 months [Time frame: 3 months ± 2 weeks after inclusion]
- CPC score within 6 months [Time frame: 6 months ± 2 weeks after inclusion]
- mRS score within 6 months [Time frame: within 6 months ± 2 weeks after inclusion]
- GOSE score within 6 months [Time frame: within 6 months ± 2 weeks after inclusion]
- Awakening within 6 months ± 2 weeks [Time frame: within 6 months ± 2 weeks after inclusion]
- CRS-R score within 6 months [Time frame: within 6 months ± 2 weeks after inclusion]
- PRECOM tool - first week of coma [Time frame: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)]
- PRECOM tool - second week of coma [Time frame: One week visit (one week after inclusion visit +/- 2 days)]
- PRECOM tool - first and second week of coma [Time frame: Inclusion and one week visits]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 7 centers
- APHP Avicenne Hospital - Réanimation médico-chirurgicale — Bobigny
- APHP Lariboisière Hospital, Clinical Physiology Department — Paris
- APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique — Paris
- APHP Cochin Hospital - médecine intensive-réanimation — Paris
- APHP HEGP hospital - Réanimation médicale — Paris
- APHP Bichat Hospital -Médecine intensive - réanimation infectieuse — Paris
- Delafontaine Hospital - médecine intensive-réanimation — Saint-Denis
Identifiers
NCT: NCT05321459 · AOR 20045