Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206473
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-01-04
Brief Title:
Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients Diagnostic and Prognostic Electrophysiological Signatures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DeSign
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00279-36 | OTHER | ID-RCB | None |