NCT06089538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

September 13, 2023

Last Update Submit

October 12, 2023

Conditions

Cognitive Dysfunction

Keywords

deliriumacute respiratory distress syndrome (ARDS)P300N400self-processingsemantic primingfunctional connectivity

Outcome Measures

Primary Outcomes (6)

  • Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured 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: weighted Symbolic Mutual Information (wSMI) measured by presence or absence of the signal

    Baseline

  • Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured 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: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)

    Baseline

  • Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured 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: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)

    Baseline

  • Presence or absence of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) six months after phase of delirium

    Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by presence or absence of the signal

    6 months

  • Amplitude of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

    Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by amplitude (microvolts)

    6 months

  • Latency of the signal of weighted Symbolic Mutual Information (wSMI) measured by multidimensional ElectroEncephaloGram (mEEG) at the acute phase of delirium

    Analysis of data from the multidimensional electrophysiological battery (mEEG) six months after phase of delirium: weighted Symbolic Mutual Information (wSMI) measured by latency (milliseconds)

    6 months

Study Arms (2)

Delirium patients group

EXPERIMENTAL

Patients admitted for acute respiratory distress syndrome (ARDS) who developed delirium

Diagnostic Test: mEEG battery

Patients without delirium

ACTIVE COMPARATOR

Patients admitted for acute respiratory distress syndrome (ARDS) who did not developed delirium

Diagnostic Test: mEEG battery

Interventions

mEEG batteryDIAGNOSTIC_TEST

The 2 groups will be assessed twice : in the acute phase of acute respiratory distress syndrome (ARDS) at patient's bedside in the intensive care unit (ICU) using an mEEG battery (electrophysiological acquisition at rest and during complex cognitive stimulation), and a simple clinical neuropsychological assessment ; 6 months ± 2 weeks later using the same mEEG battery and a multi-domain clinical neurocognitive and psychological assessment battery

Delirium patients groupPatients without delirium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the intensive care unit with ARDS (according to Berlin criteria)
  • Membership of a social security scheme
  • Signed consent of the patient (group without delirium) or referring person (group with delirium)
  • Discontinuation of any sedative agent for ≥ 72 hours

You may not qualify if:

  • Pre-existing psychotic disorders
  • Pre-existing cognitive deficits
  • Patients with chronic ethylism
  • Previous neurological history
  • 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 women
  • Patients under court protection
  • Patients who have already participated in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Cognitive DysfunctionDeliriumRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • William BUFFIERES, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William BUFFIERES, MD

CONTACT

561779435buffieres.w@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 18, 2023

Study Start

October 30, 2023

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

FR(1)