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Clinical Trials in Czechia / NCT05891873
Recruiting Observational

Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations

NCT05891873 · tracked via the Priya Life Science Czechia tracker
Sponsor
Masaryk University
Phase
Observational
Started
2023-09-07
Last updated
2023-10-23

Condition(s) studied

Delirium

Investigational drug(s) / intervention(s)

CAM-ICUICDSC4ATp(s)CAM-ICUCAPDMASTcz (The Mississippi Aphasia Screening Test)EEG

CAM-ICU: Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

ICDSC: Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

4AT: Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

p(s)CAM-ICU: Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

CAPD: Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

MASTcz (The Mississippi Aphasia Screening Test): People with aphasia will be examined by a skilled speech therapist.

EEG: Patients with positive delirium will undergo EEG examination. 10-min native EEG.

Study summary

Intensive and critical care in the intensive care unit (ICU) is often associated with ICU delirium and post-ICU dementia, regardless of the nature of the primary disease or insult. Optimal practical management of ICU delirium including its screening, prevention, and treatment, is an integral part of the current recommendations for optimal ICU care, but there are large gaps in the knowledge about the optimal and most effective prevention and treatment of this complication. Information on the actual implementation of these recommendations in the Czech Republic is lacking. The diagnosis of delirium is particularly challenging in neurointensive care patients (due to overlap with symptoms of primary brain lesions) and in a paediatric population. A complementary multicentre observational 4-year follow-up study, performed in an adult neurointensive/critical care stroke cohort and in a paediatric intensive/critical care cohort in centres following currently recommended preventive measures (Delusion-deep-cz) will investigate the incidence of ICU delirium and post-ICU dementia and their modifiable and non-modifiable predisposing and precipitating risk factors. Objectives are to determine the optimal methods for diagnostic screening of these complications and for the differential diagnosis of conditions mimicking delirium (non-convulsive epileptic state) or symptoms hindering its diagnosis (aphasia), and to study the association between sleep disturbances and ICU delirium to verify the role of sleep in the pathophysiology of delirium.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB). * Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care). Exclusion Criteria: * (N-ICU) severe trauma with short life expectancy (days) * duration of the ICU stay shorter than 24 hours

Primary outcome measure(s)

  • Number of participants who develop ICU delirium — up to 14 days after admission
    assessed by experienced neuro-intensivist

Trial sites (1)

FacilityCityRegionStatus
Brno University Hospital Brno Czechia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05891873 on ClinicalTrials.gov ↗ ← All trials in Czechia