NCT03735940

Clinical Evaluation Program of DeltaScan (ICU)

Terminated NA Last updated 19 August 2022

What this trial tests

NA trial testing Spot monitoring device, excl. Sham in Delirium in 3,630 participants. Terminated before completion.

Timeline

1 March 2019

Primary endpoint
1 June 2021

29 June 2021

Quick facts

Lead sponsor	UMC Utrecht
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	3,630
Start date	1 March 2019
Primary completion	1 June 2021
Estimated completion	29 June 2021
Sites	1 location across Netherlands

Drugs / interventions tested

• Spot monitoring device, excl. Sham

Conditions studied

• Delirium — all drugs for Delirium →

Sponsor

UMC Utrecht — full company profile →

Who can join

18 and older, any sex, with Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.