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临床试验/NCT06206473
NCT06206473撤回不适用

Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients: Diagnostic and Prognostic Electrophysiological Signatures

University Hospital, Toulouse0 个研究点目标入组 30 人开始时间: 2025年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
30
主要终点
Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

研究概览

简要总结

Early cognitive assessment of critically-ill acute respiratory distress syndrome (ARDS) patients with delirium using a multidimensional electrophysiological evaluation battery (mEEG) to identify and characterize the neural correlates of cognitive dysfunctions associated with delirium (vigilance, attention, semantic and lexical processing, self-processing), and to develop a prognostic evaluation of neurocognitive and psychological disorders using an innovative non-behavioral approach.

详细描述

Delirium is an altered mental status associated with specific manifestations such as reduced ability to direct, focus, maintain and shift attention (DSM V criteria). The vulnerability of critically-ill ARDS patients explains the high incidence of delirium (up to 80%) in this setting. Delirium is an independent predictor of post-traumatic stress disorder, long term cognitive decline and mortality. To reduce this medical and social burden, a more complete description of delirium is needed both in terms of cognitive impairments and long term neurological and neuropsychological impact. Actually, it could be argued that the current exclusive behavioral assessment of these patients is insufficient in terms of diagnosis and prognostic assessment. In recent years, the study of consciousness has made major progress thanks to the use of innovative electrophysiological exploration methods. This work has notably allowed the development of new non-behavioral tools for the exploration of brain function in brain damaged patients in response to complex auditory stimulations (multidimensional electrophysiological battery, mEEG). In this context, the investigator team has recently demonstrated alterations in cognitive functions related to language- and self-processing in ARDS patients with severe acute respiratory syndrome (SARS)-CoV2 infection. These electrophysiological cognitive alterations were particularly marked in COVID-19 patients with delirium. Further studies are needed to disentangle the cognitive impact specifically related to delirium from that related to a severe form of COVID-19. The primary objective of this study is to identify diagnostic electrophysiological signatures of cognitive dysfunctions associated with the acute phase of delirium in critically-ill ARDS patients using a multidimensional electrophysiological assessment (mEEG) recording at rest and during auditory stimulation (first visit, V1). Secondary objectives are to characterize the impact of intensive care unit (ICU)-related delirium on neurocognitive and psychological dysfunctions observed at 6 months (second visit, V2), in order to explore the prognostic predictive value of electrophysiological data acquired during the acute phase of delirium.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to the intensive care unit with ARDS (according to Berlin criteria)
  • Delirium (according to Confusion Assessment Method (CAM)-ICU criteria)
  • Membership of a social security scheme
  • Signed consent of the referring person
  • Discontinuation of any sedative agent for ≥ 72 hours

排除标准

  • Pre-existing psychotic disorders
  • Pre-existing cognitive deficits (short Informant Questionnaire on Cognitive Decline in the Elderly (short IQCODE) ≥ 3,4)
  • Recent ICU admission (> 5 days of ICU hospitalization within 6 months prior to current ICU admission)
  • Patients whose delirium cannot be reliably assessed due to blindness, deafness or inability to speak French
  • Patients whose life expectancy is unlikely to exceed 24 hours
  • Pregnant ans breastfeeding women
  • Patients under court protection
  • Patients who have already participated in the study

研究组 & 干预措施

ICU patients with ARDS and delirium

Experimental

ICU patients with ARDS and delirium will be assessed twice: in the acute phase of ICU-related delirium (V1) using an mEEG battery (electrophysiological acquisition at rest and during complex cognitive stimulation), and 6 months ± 2 weeks later (V2) using a multi-domain clinical neurocognitive and psychological assessment battery.

干预措施: mEEG assessment (Other)

结局指标

主要结局

Functional connectivity: weighted Symbolic Mutual Information (wSMI) measured at rest by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

时间窗: Baseline

Analysis of data from the multidimensional electrophysiological battery (mEEG) at rest during the acute phase of delirium: continuous value (between 0 and 1) of weighted Symbolic Mutual Information (wSMI)

Event-related potentials measured during auditory stimulation by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

时间窗: Baseline

Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: subject's own name effect (subject's own name vs other first name) measured by spatio-temporal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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