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Read our disclaimer for details. Last Update Posted : July 15, Delirium detection using relative delta power based on 1-minute single-channel EEG: a multicentre study.
Br J Anaesth. Epub Oct 2. Delirium detection using EEG: what and how to measure. 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 6 non-ICU departments.
Study population: Elderly admitted to non-ICU departments with high risk of delirium. Intervention: During 12 months, frail elderly admitted to a non-ICU department of participating hospitals with high risk of delirium will be included in the study.
First, all hospitals will apply 'usual care' to all patients, i. Delirium Observation Screening DOS 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 5 weeks, 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. Primary endpoints: delirium detection rate i. 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 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 minutes depending on the screening tools that is used.
Based on the above we consider the burden to participants in this study to be minimal. Layout table for study information Study Type : Interventional Clinical Trial Actual Enrollment : participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: In this study hospital 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. We marked the first wave of the COVID 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. Sham 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. During the intervention phase the DeltaScan will be used on the exact same moments, i. Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Delirium detection rate [ Time Frame: From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months ] 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. Length of admission days [ Time Frame: From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months ] The duration of admission will be defined as the length of stay in the non-ICU hospital department in case of intermediate ICU admission: the cumulative duration of stay in the non-ICU department that participates in this study.
The criteria for discharge will be the same in the usual care period and the intervention period. Secondary Outcome Measures : The time interval between admission i. Delirium incidence [ Time Frame: From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months ] Hospital mortality [ Time Frame: From date of admission on the ward until date of death from any cause during hospitalization, assessed up to 12 months ] Direct medical costs of hospitalization [ Time Frame: From date of admission on the ward until date of discharge from the ward or death from any cause, whichever came first, assessed up to 12 months ] 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.
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