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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54010
Enrollment
290
Registered
2021-12-16
Start date
2022-03-12
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

confusion Encephalopathy

Interventions

In the intervention group, the DeltaScan measurement result will be visually presented to the medical team in the patient data management system (PDMS), during daily medical rounds. PDMS then sugges

Sponsors

HagaZiekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Primary endpoint is the ICU length of stay, which will be measured in hours.

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)