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

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.

Conditions

• Delirium

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Tergooi Hospital

  collaborator OTHER

• Franciscus Gasthuis

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Isala

  collaborator OTHER

• OLVG

  collaborator NETWORK

• St. Antonius Hospital

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Prolira

  collaborator INDUSTRY

• European Union

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-16

Primary Completion

2021-02-12

Completion

2021-02-12

Countries

• Netherlands

Study Locations