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

July 9, 2021 updated by: A.J.C. Slooter, UMC Utrecht

A Prospective Multicenter Clinical Validation Study of DeltaScan for the Assessment of Delirium in the Intensive Care Unit and on Wards

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

434

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, Postbus 85500
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the ICU or the ward

Description

Inclusion Criteria:

  • Admitted to the ICU or ward ICU patients: Richmond Agitation-Sedation Scale (RASS) score of -2 or higher Ward patients: aged 70 years or older
  • Per the Instructions of Use of DeltaScan the patient has to be continuously awake at the time of the EEG measurement

Exclusion Criteria:

  • Age younger than 18 years.
  • Acute macro brain injury in 6 weeks prior to the DeltaScan measurement (such as postanoxic encephalopathy or traumatic brain injury).
  • Admitted because of a primary neurological or neurosurgical disease
  • Patients with severe agitation hampering measurement with DeltaScan.
  • Patients who cannot clinically be assessed for delirium, e.g. due to a language barrier or deafness.
  • Patients using lithium
  • Patients with a metal plate or a metal device in the head
  • Known pre-existing dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Delirium positive
Delirium negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The positive and negative predictive value of DeltaScan
Time Frame: The predictive value of DeltaScan is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.

Using positive and negative predictive values, the diagnostic performance of the DeltaScan will be assessed separately in patients admitted to an ICU, and elderly patients admitted to the ward.

A specific focus will be on a high negative predictive value (NPV) because it is important not to miss delirium. A lower positive predictive value (PPV) is acceptable, as the subsequent step in the management of patients with a positive Delta scan will be further diagnostic testing, which is clinically considered to have a lower risk compared to missed delirium.
The predictive value of DeltaScan is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of DeltaScan
Time Frame: Sensitivity and Specificity of DeltaScan is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
To investigate the diagnostic performance in terms of sensitivity and specificity of the DeltaScan, separately in patients admitted to an ICU, and elderly patients admitted to a ward.
Sensitivity and Specificity of DeltaScan is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
Proportion of successful DeltaScan measurements
Time Frame: From date of study start until the date of study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
The proportion of successful DeltaScan measurements, meaning the number of patients with a positive or negative test result in relation to the total number of patients tested with DeltaScan.
From date of study start until the date of study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
Repeatability of DeltaScan's Delirium Probability Score during three consecutive DeltaScan measurements
Time Frame: From date of study start until the date of study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
The variability of DeltaScan's Delirium Probability Score (on a scale from 1 (low probability of delirium) to 5 (high probability of delirium)) in patients scored as delirious, non-delirious and indeterminate across three measurements performed within a short time frame of 30 minutes. This will be done in a subsample of 30 delirious patients and 30 non-delirious patients.
From date of study start until the date of study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in positive and negative predictive values of DeltaScan between age subgroups on the ICU
Time Frame: The change in positive and negative predictive values between age groups is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.
Change in positive and negative predictive values of DeltaScan between ICU patients older than 60 years and patients 18 to 60 years old, in order to assess generalizability to younger patients.
The change in positive and negative predictive values between age groups is assessed through study completion. Each patient is assessed only once, at a random time between admission and discharge to the ICU/nursing ward, for a maximum of 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Radboud University Medical Center
Erasmus Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
St. Antonius Hospital
European Union
Franciscus Gasthuis
Diakonessenhuis, Utrecht
OLVG
Isala
Prolira
Amphia Hospital
Tergooi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2019

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

February 12, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-857/C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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