The EARLY DELTA Trial

Critical Illness Clinical Trial

— EARLY DELTA  

Official title:

The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403268
• Other study ID #: T21-064
• Secondary ID: NL78854.041.21
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: March 2, 2026

Study information

• Verified date: July 2023
• Source: HagaZiekenhuis
• Contact: Eline Pellekoorn, RN
• Phone: +31702104955
• Email: e.pellekoorn[@]hagaziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2, 2026
• Est. primary completion date: March 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Critical Illness
• Delirium

Intervention

Device:
• DeltaScan
Twice daily DeltaScan observations

Locations

Country	Name	City	State
Netherlands	HagaZiekenhuis	Den Haag	Zuid Holland
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Ottens	Dutch Society of Intensive Care, Prolira

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Encephalopathy/delirium occurrence (DeltaScan)	Defined as: any DeltaScan score = 3 OR initiation of antipsychotic treatment	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	Delirium occurrence (ICDSC)	Defined as: any ICDSC score = 4 OR initiation of antipsychotic treatment	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	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)	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
Secondary	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	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
Secondary	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)	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
Secondary	ICU mortality rate	Defined as death occurring before ICU discharge. Outcome reported as proportion of participants who died before ICU discharge.	This is assessed at the date of death. In ICU survivors, it is assessed at the 90 day post-discharge follow-up
Secondary	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.	This outcome is only scored when an unplanned re-admission occurs within the first 90 days after ICU discharge.
Secondary	Hospital length-of-stay	Outcome reported in days	Assessed at the 90 day post-discharge follow-up
Secondary	Hospital mortality rate	Defined as death occurring before hospital discharge. Outcome reported as proportion of participants who died before hospital discharge.	This is assessed at the date of death. In survivors, it is assessed at the 90 day post-discharge follow-up
Secondary	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	Assessed at the 90 day post-discharge follow-up
Secondary	ICU Sedative Drug requirement	The cumulative doses of the following sedative drugs, administered after randomisation: propofol, clonidine, dexmedetomidine, esketamine, zopiclone, benzodiazepines	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	ICU opioid requirement	The cumulative doses of opioids, administered after randomisation	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	ICU antipsychotic drug requirement	cumulative dose of the following antipsychotic drugs, administered after randomisation: haloperidol, quetiapine, other antipsychotic drugs	Assessed at ICU Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	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	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	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	Assessed daily, until participant is discharged from ICU, or until the maximum observation time (30 days)
Secondary	Self-assessed quality of life	Self-assessed quality of life measured with the Euroqol Quality of Life questionnaire, version EQ6D	Assessed one year after ICU discharge
Secondary	Self assessed cognitive function	Self-assessed cognitive function measured with the cognitive failure questionnaire (CFQ, Merckelbach, Muris & Nijman 1996)	Assessed one year after ICU discharge
Secondary	Self assessed mood and depression symptoms	Self assessed mood and depression symptoms measured with the Patient Health Questionnaire (PHQ-9)	Assessed one year after ICU discharge
Secondary	Self assessed mobility and physical functioning	Self assessed mobility and physical functioning measured with the Barthel Index	Assessed one year after ICU discharge