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

NCT03966274 | Completed

• 1 other identifier: 17-857/C
• Study Type: observational
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Electroencephalography; Acute Confusion; Neurobehavioral Manifestations; Encephalopathy; Neurocognitive Disorders; Mental Disorders; Acute Brain Failure

Outcome Measures

Primary Outcomes (1)

• The positive and negative predictive value of DeltaScan

  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 Outcomes (3)

• 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.

• 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.

• 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.

Other Outcomes (1)

• 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.

Study Arms (2)

Delirium positive

Delirium negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU or the ward

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

UMC Utrecht

Utrecht, Postbus 85500, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30579407 BACKGROUND

• 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.

  PMID: 25166725 BACKGROUND

MeSH Terms

Conditions

Delirium; Neurobehavioral Manifestations; Brain Diseases; Neurocognitive Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Neuropsychiatry

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 29, 2019
• Study Start: February 16, 2019
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)