The EARLY DELTA Trial

Launched by THOMAS OTTENS · May 30, 2022

Keywords

ClinConnect Summary

The EARLY DELTA Trial is a study looking at how well a special medical device called DeltaScan can help detect delirium in critically ill patients in the ICU. Delirium is a serious condition that affects a person's ability to think and stay alert, often caused by other medical problems. This trial aims to see if using DeltaScan, which measures brain activity through a quick and harmless EEG test, can help doctors identify delirium earlier and improve patient outcomes, such as the length of time spent in the ICU and overall recovery.

To participate in this trial, patients need to be adults (18 years or older) who are admitted to the ICU and are expected to stay for at least 48 hours. They should be able to follow simple instructions and be awake or only slightly sedated. Participants will either receive standard care or standard care plus the DeltaScan measurements twice a day, which will help doctors make better decisions about treatment. Importantly, the study is designed to be safe, and the EEG test does not pose any additional risks to patients.

Gender

ALL

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