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

Sponsor

UMC Utrecht (Other)

Overall Status

Completed

CT.gov ID

NCT03966274

Collaborator

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

434

Enrollment

Location

23.9

Actual Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Delirium

Study Design

Study Type:

Observational

Actual Enrollment :

434 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 16, 2019

Actual Primary Completion Date :

Feb 12, 2021

Actual Study Completion Date :

Feb 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Delirium positive
Delirium negative

Outcome Measures

Primary Outcome Measures

The positive and negative predictive value of DeltaScan [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.

Secondary Outcome Measures

Sensitivity and Specificity of DeltaScan [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.
Proportion of successful DeltaScan measurements [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.
Repeatability of DeltaScan's Delirium Probability Score during three consecutive DeltaScan measurements [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.

Other Outcome Measures

Change in positive and negative predictive values of DeltaScan between age subgroups on the ICU [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.