Clinical trial NCT03966274: DeltaScan Validation Study for the Assessment of Delirium in the ICU and on Wards
Official title: A Prospective Multicenter Clinical Validation Study of DeltaScan for the Assessment of Delirium in the Intensive Care Unit and on Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Electroencephalography
Acute Confusion
Neurobehavioral Manifestations
Encephalopathy
Neurocognitive Disorders
Mental Disorders
Acute Brain Failure
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Tergooi Hospital
name: Franciscus Gasthuis
name: Erasmus Medical Center
name: Isala
name: OLVG
name: St. Antonius Hospital
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Diakonessenhuis, Utrecht
name: Amphia Hospital
name: Prolira
name: European Union
First posted: 2019-05-29
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU or the ward

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The positive and negative predictive value of DeltaScan
timeFrame: 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 outcomes:
measure: Sensitivity and Specificity of DeltaScan
timeFrame: 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.
measure: Proportion of successful DeltaScan measurements
timeFrame: 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.
measure: Repeatability of DeltaScan's Delirium Probability Score during three consecutive DeltaScan measurements
timeFrame: 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 outcomes:
measure: Change in positive and negative predictive values of DeltaScan between age subgroups on the ICU
timeFrame: 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.
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
citation: Numan T, van den Boogaard M, Kamper AM, Rood PJT, Peelen LM, Slooter AJC; Dutch Delirium Detection Study Group. Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study. Br J Anaesth. 2019 Jan;122(1):60-68. doi: 10.1016/j.bja.2018.08.021. Epub 2018 Oct 2.
citation: van der Kooi AW, Zaal IJ, Klijn FA, Koek HL, Meijer RC, Leijten FS, Slooter AJ. Delirium detection using EEG: what and how to measure. Chest. 2015 Jan;147(1):94-101. doi: 10.1378/chest.13-3050.