Clinical trial NCT05403268: The EARLY DELTA Trial
Official title: The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delirium
Critical Illness
Acute Encephalopathy
Keywords: acute encephalopathy
delirium
critical illness
intensive care unit
automated EEG
electroencephalography
Lead sponsor: HagaZiekenhuis
Sponsor class: OTHER
Collaborators: name: Prolira
name: Dutch Society of Intensive Care
First posted: 2022-06-03
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 2 parallel arms: control group (usual care) and intervention group.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: ICU length of stay
timeFrame: Assessed at the 90 day post discharge follow-up
Secondary outcomes:
measure: Encephalopathy/delirium occurrence (DeltaScan)
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: Delirium occurrence (ICDSC)
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: ICU encephalopathy/delirium and coma free days (reported as: composite, delirium free days, coma free days)
timeFrame: 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
measure: ICU ventilator free days
timeFrame: 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
measure: ICU organ support free days
timeFrame: 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
measure: ICU mortality rate
timeFrame: This is assessed at the date of death. In ICU survivors, it is assessed at the 90 day post-discharge follow-up
measure: ICU readmission rate
timeFrame: This outcome is only scored when an unplanned re-admission occurs within the first 90 days after ICU discharge.
measure: Hospital length-of-stay
timeFrame: Assessed at the 90 day post-discharge follow-up
measure: Hospital mortality rate
timeFrame: This is assessed at the date of death. In survivors, it is assessed at the 90 day post-discharge follow-up
measure: 90 day mortality rate
timeFrame: Assessed at the 90 day post-discharge follow-up
measure: ICU Sedative Drug requirement
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: ICU opioid requirement
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: ICU antipsychotic drug requirement
timeFrame: Assessed at ICU Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: ICU accidental device removal incidence and falls
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: ICU incidence and duration of the use of physical restraints
timeFrame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
measure: Self-assessed quality of life
timeFrame: Assessed one year after ICU discharge
measure: Self assessed cognitive function
timeFrame: Assessed one year after ICU discharge
measure: Self assessed mood and depression symptoms
timeFrame: Assessed one year after ICU discharge
measure: Self assessed mobility and physical functioning
timeFrame: Assessed one year after ICU discharge
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
state: Zuid Holland
Study officials:
affiliation: HagaZiekenhuis
name: Thomas H Ottens, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: