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WithdrawnNo phase

Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients

Key facts

Who runs it
University Hospital, Toulouse
Trial code
Status
Withdrawn
Started
9 Oct 2025
Ended
9 Oct 2025
Type of study
Interventional
Treatments tested
  • mEEG assessment
Record updated
29 June 2026
Why it stopped
material issue

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Recent ICU admission (> 5 days of ICU hospitalization within 6 months prior to current ICU admission)
  • Pre-existing psychotic disorders
  • Pre-existing cognitive deficits (short Informant Questionnaire on Cognitive Decline in the Elderly (short IQCODE) ≥ 3,4)
  • 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

About the trial

What the trial wants to find out

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.

The group in the trial

  • ICU patients with ARDS and deliriumTreatment being tested

    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.

    Treatment: mEEG assessment

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients: Diagnostic and Prognostic Electrophysiological Signatures
Record updated
29 June 2026