The EARLY DELTA Trial

NCT ID: NCT05403268

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2025-08-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: SHAM_COMPARATOR

DeltaScan

Intervention Type: DEVICE

Twice daily DeltaScan observations

Usual Care + DeltaScan

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.

Group Type: EXPERIMENTAL

DeltaScan

Intervention Type: DEVICE

Twice daily DeltaScan observations

Interventions

DeltaScan

Twice daily DeltaScan observations

Intervention Type: DEVICE

Other Intervention Names

automated 1-channel EEG

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 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prolira

INDUSTRY

Sponsor Role: collaborator

Dutch Society of Intensive Care

UNKNOWN

Sponsor Role: collaborator

Thomas Ottens

OTHER

Sponsor Role: lead

Responsible Party

Thomas Ottens

Consultant Anesthesiologist-Intensivist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas H Ottens, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

HagaZiekenhuis

Locations

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

HagaZiekenhuis

The Hague, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL78854.041.21

Identifier Type: REGISTRY

Identifier Source: secondary_id

T21-064

Identifier Type: -

Identifier Source: org_study_id