Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03735940
Other study ID # FTI-820555-DeltaScan-study1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT05891873 - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT06194474 - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A