Using EEG to detect delirium in critically ill patients
The Impact of Early Delirium Detection With DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A Randomized Controlled Trial.
This study is testing a new device that uses brain wave monitoring to help doctors spot delirium in critically ill patients more accurately and earlier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HagaZiekenhuis Academic / other |
| Locations | 2 sites (Enschede, Overijssel and 1 other locations) |
| Trial ID | NCT05403268 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of the DeltaScan device, which utilizes electroencephalography (EEG) to identify specific brain activity patterns associated with delirium in critically ill patients. By integrating EEG-based detection with traditional clinical observation scales, the study aims to enhance the sensitivity of delirium diagnosis, particularly for hypoactive cases. The goal is to facilitate earlier detection of delirium and subsyndromal delirium, potentially leading to improved clinical outcomes such as reduced delirium duration and shorter ICU stays.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are admitted to the ICU with an anticipated stay of 48 hours or longer.
Not a fit: Patients with conditions such as recent intracranial neurosurgery, known space-occupying lesions, or severe neurological disorders like dementia or Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the early detection and management of delirium in critically ill patients, enhancing their recovery and overall outcomes.
How similar studies have performed: While the use of EEG for delirium detection is a novel approach, similar studies have shown promise in enhancing diagnostic accuracy for cognitive disturbances in critical care settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Enschede, Overijssel and 1 other locations
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Not_yet_recruiting)
- HagaZiekenhuis — Den Haag, Zuid Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Thomas H Ottens, MD, MSc, PhD — HagaZiekenhuis
- Study coordinator: Eline Pellekoorn, RN
- Email: e.pellekoorn@hagaziekenhuis.nl
- Phone: +31702104955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.