The EARLY DELTA Trial (EARLY DELTA)
Delirium, Critical Illness, Acute Encephalopathy
About this trial
This is an interventional diagnostic trial for Delirium focused on measuring acute encephalopathy, delirium, critical illness, intensive care unit, automated EEG, electroencephalography
Eligibility Criteria
Inclusion Criteria:
- Adult (18 years or above) admitted to ICU for any indication
- ICU length of stay anticipated to be 48h or longer from time of screening for inclusion
- Written informed consent by patient or representative
Exclusion Criteria:
- More than 96 hours have elapsed since ICU admission
- Patient or representative decline participation
- Admission for out-of-hospital cardiac arrest, status epilepticus, hemorrhagic or ischemic stroke, increased intracranial pressure, isolated head trauma
- Recent intracranial neurosurgery (<30 days prior to inclusion)
- Known space-occupying lesions in the brain or skull
- Metal implants in brain or skull
- Diagnosis of dementia or Parkinson's disease
- Inpatient from nursing home
- Lithium use (<30 days prior to inclusion)
- Imminent death or palliative care phase
- Patients ánd their legal representatives both do not understand Dutch or English
- Patients who participated in the EARLY DELTRA trial <90 days ago
Sites / Locations
- Medisch Spectrum Twente
- HagaZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Usual Care
Usual Care + DeltaScan
Usual care group. Participants undergo twice daily DeltaScan measurements in addition to usual care. An adapted device is used, that masks the measurement result (it generates a QR-code, that is scanned into the patient data management system). The results will be unblinded one enrollment is complete.
Intervention group. Participants undergo twice daily DeltaScan measurements in addition to usual care. The measurement result is used together with routine delirium screening observations to guide management, according to the local delirium protocol.