Clinical Evaluation Program of DeltaScan (ICU)

Delirium Clinical Trial

Official title:

DeltaScan for the Assessment of Delirium in the Intensive Care: a Multicenter Stepped Wedge Cluster Randomized Trial (Study 1)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03735940
• Other study ID #: FTI-820555-DeltaScan-study1
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 29, 2021

Study information

• Verified date: August 2022
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3630
• Est. completion date: June 29, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Spot monitoring device, excl. Sham
o During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. o During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'.

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (8)

Lead Sponsor	Collaborator
UMC Utrecht	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Charite University, Berlin, Germany, European Union, Factory CRO, Implementation IQ, KU Leuven, Prolira

Country where clinical trial is conducted

Netherlands, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		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	Sex		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	Type of admission, defined as acute or elective		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	Admitting discipline, defined as medicine, general surgery, cardiology, or cardiothoracic surgery		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	Reason for not using DeltaScan		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
Primary	Delirium detection rate	The detection rate of delirium will be defined as the proportion of delirium positive assessments during conditions that a patient can be assessed for delirium. A positive delirium assessment in the usual care period will be defined as a positive score on the delirium detection tool that is currently used in the participating department according to the protocol of that department. A positive delirium assessment in the intervention period will be defined as a DeltaScan score of 4 or 5.	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
Primary	Length of admission (days)	The duration of admission will be defined as the cumulative duration of ICU admission. The criteria for discharge will be the same in the usual care period and the intervention period.	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	The time interval between admission (i.e. ICU admission) and the first delirium positive assessment		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	The number of delirium days	This outcomes is defined as the number of days with at least one positive assessment.	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	Delirium incidence		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	Hospital mortality		From date of admission on the ICU until date of death from any cause, assessed up to 12 months
Secondary	Direct medical costs of hospitalization	We aim to collect health care consumption in detail for every included patient. This health care consumption for instance consists of number of hospitalization days, medication, diagnostic procedures. These data will be extracted from the hospital systems. General reference prices (open source, National Tariffs) will be applied to this health care consumption to calculate total costs.	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	Adherence to new delirium treatment protocol	Steps that are taken (e.g. pharmacological or non-pharmacological treatment, consults of specialist etc.) by the hospital staff after a delirium screener gives a delirium positive score.	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	Duration of mechanical ventilation		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	Hospital length of stay		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
Secondary	Incidence of ICU re-admission		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
Secondary	Number of days alive without delirium and without coma (i.e. RASS -3, -4 or -5) in 28 days		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