The Impact of Early Delirium Detection with DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A randomized controlled trial.

Recruiting

Conditions: confusion
Encephalopathy
10012221

Registration Number: NL-OMON54010

Lead Sponsor: HagaZiekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 290

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the ICU length of stay, which will be measured in hours.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints observed during ICU stay:<br /><br>delirium incidence, encephalopathy/delirium/coma-free days, cumulative dose of<br /><br>sedatives, opioids and antipsychotics, incidence of accidental removal of<br /><br>lines/tubes/drains by patient, incidence and duration of use of physical<br /><br>restraints, ventilator free days, organ support free days, ICU mortality<br /><br>Secondary endpoints observed after ICU stay: ICU readmission, hospital length<br /><br>of stay, hospital mortality, 90 day mortality, 1 year self assessed quality of<br /><br>life, cognitive function, depressive symptoms and mobility/physical<br /><br>functioning.</p><br>