Clinical trial NCT03735940: Clinical Evaluation Program of DeltaScan (ICU)
Official title: DeltaScan for the Assessment of Delirium in the Intensive Care: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delirium
Keywords: Electroencephalography
Intensive Care
Brain disease
Confusion
Neurobehavioral Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: KU Leuven
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Prolira
name: Factory CRO
name: Implementation IQ
name: European Union
First posted: 2018-11-08
Enrollment: 3630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study ICU departments will be randomized with respect to the time they will introduce the DeltaScan following a stepped wedge cluster randomization design. All departments apply 'usual care' in combination with a harmonized delirium treatment protocol during the control phase. After this first time period, each new time period a department switches to the intervention period.

Due to the first wave of the COVID-19 pandemic the stepped wedge planning was interrupted. Where possible the control period and/or intervention, whichever was affected, will be extended. We marked the first wave of the COVID-19 pandemic from the 15th of March until the 15th of May or longer for a few heavily effected sites with a maximum of 6 months. Data collected during this period will not be used for primary analysis, but may be used for specific sub analyses.
Primary purpose: SCREENING

Brief summary: Rationale: Delirium, or acute brain failure, presents as an acute confusional state, and 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. The DeltaScan, a CE-certified device to detect delirium using brief EEG recording, has been recently been found have diagnostic properties that outperform the currently used screening tools.

Objective: To quantify the impact of the use of the DeltaScan on patient outcome (detection rate of delirium and duration of admission) in patients with high risk of delirium compared to the currently used delirium screening tools.

Study design: A prospective multicenter stepped wedge cluster randomized trials in (at least) 4 ICU departments.

Study population: Adult patients admitted to an intensive care unit (ICU) with high risk of delirium.

Intervention: During 12 months, patients presenting at the ICU of participating hospitals with an expected stay \> 1 day will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. standard delirium screening (e.g. the Confusion Assessment Method (CAM)-ICU) or other currently used tools) in combination with a delirium treatment protocol and subsequent management without application of the DeltaScan for a period of 3 months. Then, during a 6 month period, each 2 months, starting at day 0, randomly allocated hospitals will sequentially start to apply the DeltaScan in all eligible patients (intervention period). During the last 3 months of the study all hospitals will participate in the intervention period.

Main study endpoints:

Primary endpoints: delirium detection rate (i.e. proportion of positive assessments according to the delirium detection tool), and duration of admission at ICU. Secondary endpoints: time interval between admission and the first delirium positive assessment, number of days with at least one positive delirium assessment, delirium incidence, hospital mortality, and direct medical costs of hospitalization.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the intervention period EEG recordings 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 EEG recording will be performed two to three times daily and takes 3-4 minutes. During the usual care period the patients will receive the standard delirium screening tool for delirium assessment by a nurse. This assessment will be performed two to three times daily and takes 2-4 minutes depending on the screening tools that is used. Since the DeltaScan has shown to have superior diagnostic performance compared to the DSM5 the burden/risk of misclassification is lower than with the current standard for delirium assessment. Based on the above we consider the burden to participants in this study to be minimal.


Eligibility criteria: Inclusion Criteria:

* Admitted to the ICU department
* At risk of delirium, defined according to local protocol:

ICU patients: when expected stay is \> 1 day

Exclusion Criteria:

* Age younger than 18 years.
* Admitted because of a primary neurological or neurosurgical disease.
* Patients who cannot clinically assessed for delirium, e.g. due to a language barrier or deafness.
* Known pre-existing dementia.
* We decided to add an extra exclusion criteria: Patients infected with SARS-CoV-19 infection

Primary outcomes:
measure: Delirium detection rate
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Length of admission (days)
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Secondary outcomes:
measure: The time interval between admission (i.e. ICU admission) and the first delirium positive assessment
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: The number of delirium days
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Delirium incidence
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Hospital mortality
timeFrame: From date of admission on the ICU until date of death from any cause, assessed up to 12 months
measure: Direct medical costs of hospitalization
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Adherence to new delirium treatment protocol
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Duration of mechanical ventilation
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Hospital length of stay
timeFrame: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
measure: Incidence of ICU re-admission
timeFrame: From date of admission on the ICU until date of discharge from the hospital or death from any cause, whichever came first, assessed up to 12 months
measure: Number of days alive without delirium and without coma (i.e. RASS -3, -4 or -5) in 28 days
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
Other outcomes:
measure: Age
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Sex
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Type of admission, defined as acute or elective
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Admitting discipline, defined as medicine, general surgery, cardiology, or cardiothoracic surgery
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
measure: Reason for not using DeltaScan
timeFrame: From date of admission on the ICU until date of discharge from the ICU or death from any cause, whichever came first, assessed up to 12 months
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.