DeliriumEARLY DELTANCT05403268
The EARLY DELTA Trial
A study testing DeltaScan in people with Delirium and Critical Illness, run by Thomas Ottens at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Critical Illness, Acute Encephalopathy
- What is being tested?
- DeltaScan
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Mar 2022to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
HagaZiekenhuis
The Hague, South Holland, 2545 AA
About this study
Official title: The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.
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.
Read more
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
- Being tested
- DeltaScan
- Keywords
- acute encephalopathy, delirium, critical illness, intensive care unit, automated EEG, electroencephalography
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeltaScanDevice
Also called automated 1-channel EEG
Twice daily DeltaScan observations
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DeltaScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
Length of stay in the intensive care unit, measured in hours
Measured: Assessed at the 90 day post discharge follow-up
Secondary outcomes (19)
Encephalopathy/delirium occurrence (DeltaScan)
Defined as: any DeltaScan score ≥ 3 OR initiation of antipsychotic treatment
Measured: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Delirium occurrence (ICDSC)
Defined as: any ICDSC score ≥ 4 OR initiation of antipsychotic treatment
Measured: 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)
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without delirium or coma. We will calculate this value separately based on DeltaScan alone, DeltaScan+ICDSC and ICDSC alone)
Measured: 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
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation, regardless of ventilation mode or route. High-flow nasal oxygen (HFNO) will not be regarded as ventilation. If patients are ventilated with a device provided by another institute (i.e. Centrum voor Thuisbeademing), only days spent on the ICU ventilator will be counted. Any day with <12h of mechanical ventilation will be counted as 0,5 day. More than 12h of mechanical ventilation will be counted as 1 day
Measured: 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
Defined as: the number of days in the first 14 days after the patient was randomized during which the patient was alive without mechanical ventilation (any modality), HFNO, renal replacement therapy (any modality), mechanical circulatory support (ECLS, IABP, Impella), intravenous inotropes (dobutamine, milrinone, enoximone, levosimendan) or vasopressors (noradrenalin > 0.25 mcg/kg/min or any dose of terlipressin / arginine vasopressin)
Measured: 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 mortality rate
Defined as death occurring before ICU discharge. Outcome reported as proportion of participants who died before ICU discharge.
Measured: This is assessed at the date of death. In ICU survivors, it is assessed at the 90 day post-discharge follow-up
ICU readmission rate
Unplanned re-admission to the ICU before hospital discharge. Outcome reported as proportion of participants who were re-admitted to ICU before hospital discharge.
Measured: This outcome is only scored when an unplanned re-admission occurs within the first 90 days after ICU discharge.
Hospital length-of-stay
Outcome reported in days
Measured: Assessed at the 90 day post-discharge follow-up
Hospital mortality rate
Defined as death occurring before hospital discharge. Outcome reported as proportion of participants who died before hospital discharge.
Measured: This is assessed at the date of death. In survivors, it is assessed at the 90 day post-discharge follow-up
90 day mortality rate
Defined as death occurring within 90 days after study enrollment. Outcome reported as proportion of participants who died before 90d follow-up
Measured: Assessed at the 90 day post-discharge follow-up
ICU Sedative Drug requirement
The cumulative doses of the following sedative drugs, administered after randomisation: propofol, clonidine, dexmedetomidine, esketamine, zopiclone, benzodiazepines
Measured: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU opioid requirement
The cumulative doses of opioids, administered after randomisation
Measured: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU antipsychotic drug requirement
cumulative dose of the following antipsychotic drugs, administered after randomisation: haloperidol, quetiapine, other antipsychotic drugs
Measured: Assessed at ICU Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU accidental device removal incidence and falls
Defined as the number of incidents where a patient accidentally removes an indwelling catheter, tube, infusion line or drain (e.g. intravenous lines, wound drains, airway device, feeding tubes etc) or falls out of bed
Measured: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU incidence and duration of the use of physical restraints
Defined as the frequency of application of physical restraints and the cumulative duration of restraint application during ICU admission
Measured: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Self-assessed quality of life
Self-assessed quality of life measured with the Euroqol Quality of Life questionnaire, version EQ6D
Measured: Assessed one year after ICU discharge
Self assessed cognitive function
Self-assessed cognitive function measured with the cognitive failure questionnaire (CFQ, Merckelbach, Muris \& Nijman 1996)
Measured: Assessed one year after ICU discharge
Self assessed mood and depression symptoms
Self assessed mood and depression symptoms measured with the Patient Health Questionnaire (PHQ-9)
Measured: Assessed one year after ICU discharge
Self assessed mobility and physical functioning
Self assessed mobility and physical functioning measured with the Barthel Index
Measured: Assessed one year after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start2 Mar 2022
- Primary completion4 Nov 2024
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 parallel arms: control group (usual care) and intervention group.
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Ottens
- Sponsor type
- University, hospital or other
- Collaborators
- Prolira, Dutch Society of Intensive Care
- Responsible party
- Sponsor-investigator, Thomas Ottens, HagaZiekenhuis
- Investigators
- Thomas H Ottens, MD, MSc, PhD, Principal investigator, HagaZiekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403268
- Sponsor's protocol ID
- T21-064
- Other IDs
- NL78854.041.21
- Acronym
- EARLY DELTA
- Status last verified
- Aug 2025
- First submitted
- 13 May 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05403268
- Acronym / sponsor ID
- EARLY DELTA / T21-064
- Conditions
- Delirium, Critical Illness, Acute Encephalopathy
- Keywords
- acute encephalopathy, delirium, critical illness, intensive care unit, automated EEG, electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Thomas OttensUniversity, hospital or other
- Collaborators
- Prolira, Dutch Society of Intensive Care
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 parallel arms: control group (usual care) and intervention group.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Sham comparator | Device: DeltaScanUsual 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. |
| Usual Care + DeltaScan | Experimental | Device: DeltaScanIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeltaScanAlso: automated 1-channel EEGTwice daily DeltaScan observations | Device | Usual Care, Usual Care + DeltaScan |
Primary outcome
ICU length of stay
Time frame: Assessed at the 90 day post discharge follow-up
Length of stay in the intensive care unit, measured in hours
19 secondary outcomes
Encephalopathy/delirium occurrence (DeltaScan)
Time frame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Delirium occurrence (ICDSC)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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 mortality rate
Time frame: This is assessed at the date of death. In ICU survivors, it is assessed at the 90 day post-discharge follow-up
ICU readmission rate
Time frame: This outcome is only scored when an unplanned re-admission occurs within the first 90 days after ICU discharge.
Hospital length-of-stay
Time frame: Assessed at the 90 day post-discharge follow-up
Hospital mortality rate
Time frame: This is assessed at the date of death. In survivors, it is assessed at the 90 day post-discharge follow-up
90 day mortality rate
Time frame: Assessed at the 90 day post-discharge follow-up
ICU Sedative Drug requirement
Time frame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU opioid requirement
Time frame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU antipsychotic drug requirement
Time frame: Assessed at ICU Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU accidental device removal incidence and falls
Time frame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
ICU incidence and duration of the use of physical restraints
Time frame: Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Self-assessed quality of life
Time frame: Assessed one year after ICU discharge
Self assessed cognitive function
Time frame: Assessed one year after ICU discharge
Self assessed mood and depression symptoms
Time frame: Assessed one year after ICU discharge
Self assessed mobility and physical functioning
Time frame: Assessed one year after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Ottens, MD, MSc, PhD principal investigator
HagaZiekenhuis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeltaScan in people with Delirium and Critical Illness, run by Thomas Ottens at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay (time frame: Assessed at the 90 day post discharge follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.