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Completed

NCT Number: NCT03966274

DeltaScan Validation Study for the Assessment of Delirium in the ICU 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.

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Key information

Conditions

Delirium Brain Diseases Central Nervous System Diseases Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Utrecht

Utrecht, Postbus 85500, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Val3

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 29, 2019
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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