confusion Encephalopathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult (18 years or above) patient admitted to the intensive care unit ICU length of stay anticipated to be 48h or longer from time of inclusion Written informed consent by patient or representative
Exclusion criteria
Exclusion criteria: - More than 48 hours have elapsed since the patient was first eligible to undergo a DeltaScan measurement after ICU admission. (A patient is eligible for DeltaScan measurements if they are a. able to cooperate with simple instructions AND b. are alert or mildly sedated no deeper than a Richmond Agitation and Sedation Score (RASS) of -2.) Admission for * -out-of-hospital cardiac arrest* -status epilepticus* -hemorrhagic or ischemic stroke* -increased intracranial pressure -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 and their legal representatives both do not understand Dutch or English Participation in the EARLY DELTRA trial <90 days ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the ICU length of stay, which will be measured in hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints observed during ICU stay: delirium incidence, encephalopathy/delirium/coma-free days, cumulative dose of sedatives, opioids and antipsychotics, incidence of accidental removal of lines/tubes/drains by patient, incidence and duration of use of physical restraints, ventilator free days, organ support free days, ICU mortality Secondary endpoints observed after ICU stay: ICU readmission, hospital length of stay, hospital mortality, 90 day mortality, 1 year self assessed quality of life, cognitive function, depressive symptoms and mobility/physical functioning. | — |
Countries
Netherlands