Cognitive Dysfunctions Associated With Delirium in Critically-ill ARDS Patients

NCT06206473 | Not Yet Recruiting

• 2 other identifiers: RC31/22/04872023-A00279-36
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Distress Syndrome; Delirium

Keywords

P300; N400; self-processing; semantic priming; functional connectivity

Outcome Measures

Primary Outcomes (13)

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

  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)

  Baseline

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

  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

  Baseline

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

  Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: local effect (local deviant tone vs local standard tone) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

  Baseline

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

  Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: global effect (global deviant tone vs global standard tone) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) during auditory stimulation at the acute phase of delirium: semantic effect (semantic unrelated words vs semantic related words) measured by spatio-temporal clustering by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to subject's own name stimuli (microvolts)

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to local deviant tones (microvolts)

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 amplitude to global deviant tones (microvolts)

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : N400 amplitude to semantic unrelated words (microvolts)

  Baseline

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

  Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to subject's own name stimuli (milliseconds)

  Baseline

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

  Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to local deviant tones (milliseconds)

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : P3 latency to global deviant tones (milliseconds)

  Baseline

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

  • Analysis of data from the multidimensional electrophysiological battery (mEEG) at the acute phase of delirium during auditory stimulation : N400 latency to semantic unrelated words (milliseconds)

  Baseline

Study Arms (1)

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.

Other: mEEG assessment

Interventions

mEEG assessment OTHER

mEEG assessment (V1) will be performed at the patient's bed within 72 hours of the diagnosis of delirium. The mEEG recording, which lasts approximately 2 hours, will be performed by one of the investigators with expertise in electrophysiological acquisition. This non-invasive assessment consists of placing an EEG net on the scalp of the participants and earphones through which the auditory stimuli will be delivered.

ICU patients with ARDS and delirium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Delirium

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fabrice FERRE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice FERRE, MD

CONTACT

0561779988; ferre.f@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center cohort (Intensive Care Unit of the Toulouse University Hospital), prospective, longitudinal, interventional, proof of concept study

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share