DeltaScan Validation Study for the Assessment of Delirium in the ICU & on

Status Completed

Clinical Trial Summary

Rationale: Delirium is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs. Early detection of delirium would allow for early treatment and improved patient outcomes, but delirium is often not recognized and treatment is therefore delayed or not applied at all. Additionally, current screening tools are subjective, so an alternative, more objective diagnostic tool for early delirium detection is desired. Objective: To investigate the diagnostic performance of the DeltaScan, a CE-certified device to detect delirium using a brief electroencephalography (EEG) recording. A single EEG recording will be obtained from patients admitted to an Intensive Care Unit (ICU), and elderly patient admitted to the ward. Study design: Cross-sectional, multicenter study. Study population: Adult patients admitted to an ICU, and elderly at the ward. Main study parameters/endpoints: (1) Delirium as assessed by an adjudication committee of three delirium experts, based on cognitive information that is collected by one experienced investigator in line with the Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-5) criteria (2) Delirium Probability as determined by DeltaScan, (3) the proportion of successful DeltaScan measurements, and (4) the repeatability of the DeltaScan measurements. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden to participants of this study is minimal. EEG recording using the CE-certified DeltaScan will be made using a strip with EEG electrodes that will be mounted to the head using self-adhesive gel. The patient will be visited by an experienced investigator, who collects information in accordance with DSM-5 criteria for delirium. This assessment will be performed once and takes about 10 minutes. Afterwards, the EEG recording will be performed once and takes a maximum of 4 minutes, and all procedures combined will take a maximum of 6-7 minutes. Both the EEG recording and the assessment are an add-on to routine care and will be performed within 30 minutes of each other.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Delirium

Clinical Trial Details

NCT number	NCT03966274
Study type	Observational
Source	UMC Utrecht
Contact
Status	Completed
Phase
Start date	February 16, 2019
Completion date	February 12, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

DeltaScan Validation Study for the Assessment of Delirium in the ICU and on Wards — Val3

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms