The EARLY DELTA Trial

NCT05403268 | Completed

• 2 other identifiers: T21-064NL78854.041.21
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: Delirium is a type of acute encephalopathy that is triggered by an underlying somatic disorder. Patients experience disturbances in attention, alertness and other cognitive functions. In patients with delirium, a characteristic electroencephalography (EEG) pattern is seen, known as polymorphic delta activity. The MDR certified medical device "Deltascan" can detect this EEG pattern. Traditional clinical delirium screening instruments are known to have limited sensitivity, in particular for detecting hypoactive delirium. We hypothesize that adding EEG based encephalopathy detection to clinical observation scales increases the sensitivity and results in earlier detection of delirium and subsyndromal delirium, resulting in improved clinical outcomes of critically ill patients, such as delirium duration, ICU length of stay or survival. Objective: This randomized controlled trial aims to study the effect of implementation of EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length of stay, sedative requirements and delirium related complications, among others) in a mixed medical and surgical intensive care unit population. Study design: a randomized controlled trial Study population: adult patients (\>18 years) admitted to the ICU for unplanned care with a minimal anticipated ICU length of stay of 48h. Intervention: either usual care, where the patients' medical team obtains regular delirium screening, versus usual care plus twice daily DeltaScan measurements. During the daily medical rounds, the DeltaScan results will be presented to the patients' medical team together with decision support, consisting of DeltaScan trend interpretation and protocol-based suggestions for evaluation of underlying delirium cause. Main study parameters/endpoints: primary endpoint will be ICU length of stay. Secondary endpoints are encephalopathy/delirium occurrence, ICU encephalopathy/delirium free days, ventilator free days, organ support free days, sedative, opioid and antipsychotic drug requirement, delirium related complication occurrence, frequency and duration of physical restraints application, ICU mortality, ICU readmission, hospital length of stay, hospital mortality and 90-day mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, it is not expected that randomization to the intervention group adds risk for patients. This is a study of a diagnostic intervention with additional encephalopathy/delirium observations consisting of a short (90 seconds) EEG measurement, which does not harm the patient. Clinicians will receive protocol-based decision support alongside the diagnostic observation. No additional medical treatments will be conducted as part of the study protocol.

Conditions

Delirium; Critical Illness; Acute Encephalopathy

Keywords

acute encephalopathy; delirium; critical illness; intensive care unit; automated EEG; electroencephalography

Outcome Measures

Primary Outcomes (1)

• ICU length of stay

  Length of stay in the intensive care unit, measured in hours

  Assessed at the 90 day post discharge follow-up

Secondary Outcomes (19)

• Encephalopathy/delirium occurrence (DeltaScan)

  Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)

• Delirium occurrence (ICDSC)

  Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)

• ICU encephalopathy/delirium and coma free days (reported as: composite, delirium free days, coma free days)

  Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death

• ICU ventilator free days

  Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death

• ICU organ support free days

  Assessed at the 14th day after ICU admission. If the patient dies during the first 14 days of the study observation period, this outcome is assessed at the date of death

Study Arms (2)

Usual Care

SHAM COMPARATOR

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.

Device: DeltaScan

Usual Care + DeltaScan

EXPERIMENTAL

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.

Device: DeltaScan

Interventions

DeltaScan DEVICE

Twice daily DeltaScan observations

Also known as: automated 1-channel EEG

Usual Care; Usual Care + DeltaScan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18 years or above) admitted to ICU for any indication
• Written informed consent by patient or representative

You may not qualify if:

• 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 of -2.
• Admission for out-of-hospital cardiac arrest, status epilepticus, hemorrhagic or ischemic stroke, increased intracranial pressure, head trauma
• 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
• 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

Sponsors & Collaborators

• Thomas Ottens: lead
• Prolira: collaborator
• Dutch Society of Intensive Care: collaborator

Study Sites (2)

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

HagaZiekenhuis

The Hague, South Holland, 2545 AA, Netherlands

Location

MeSH Terms

Conditions

Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Thomas H Ottens, MD, MSc, PhD

  HagaZiekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Usual care group undergoes DeltaScan measurements with blinded device to prevent the measurement result from influencing clinical decisions.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Anesthesiologist-Intensivist

Model Details: Randomized controlled trial with 2 parallel arms: control group (usual care) and intervention group.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 3, 2022
• Study Start: March 2, 2022
• Primary Completion: November 4, 2024
• Study Completion: August 19, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)