Predictive Outcome in Comatose Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Neurological prognosis.
- Кому может быть актуально
- Состояния в реестре: Coma, Heart Arrest, Cardiopulmonary Resuscitation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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
Первичные конечные точки
- Awakening within 3 months [Срок оценки: within 3 months ± 2 weeks after inclusion]
Вторичные конечные точки (12)
- CPC score within 3 months [Срок оценки: 3 months ± 2 weeks after inclusion]
- mRS score within 3 months [Срок оценки: 3 months ± 2 weeks after inclusion]
- FOUR score within 3 months [Срок оценки: 3 months ± 2 weeks after inclusion]
- GOSE score within 3 months [Срок оценки: 3 months ± 2 weeks after inclusion]
- CPC score within 6 months [Срок оценки: 6 months ± 2 weeks after inclusion]
- mRS score within 6 months [Срок оценки: within 6 months ± 2 weeks after inclusion]
- GOSE score within 6 months [Срок оценки: within 6 months ± 2 weeks after inclusion]
- Awakening within 6 months ± 2 weeks [Срок оценки: within 6 months ± 2 weeks after inclusion]
- CRS-R score within 6 months [Срок оценки: within 6 months ± 2 weeks after inclusion]
- PRECOM tool - first week of coma [Срок оценки: Inclusion visit (3 to 7 days after cardiac arrest +/- 2 days if week-end)]
- PRECOM tool - second week of coma [Срок оценки: One week visit (one week after inclusion visit +/- 2 days)]
- PRECOM tool - first and second week of coma [Срок оценки: Inclusion and one week visits]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 7 центров
- 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
Идентификаторы
NCT: NCT05321459 · AOR 20045