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

NCT ID: NCT05891873

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

Design

• Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months.

Recruitment (groups)

1. 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).

2. 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).

General working hypotheses

• Current recommendations for the practical management (PADIS) and prevention of delirium lead to a decrease in the incidence of ICU-delirium and post-ICU dementia and may also change the spectrum of significant risk factors.
• In the Czech Republic, both general knowledge and practical implementation of these recommendations may be low.
• Currently recommended screening instruments for ICU-delirium are valid and reliable in both adult and paediatric cohorts of (neuro)intensive/critical patients and can replace the expert assessment using DSM-IV or V criteria (The Diagnostic and Statistical Manual of Mental Illnesses).
• Non-convulsive status epilepticus (NCSE) may mimic ICU-delirium and a routine EEG exam in patients meeting the criteria for ICU delirium may be helpful.
• Aphasia may complicate the diagnosis of delirium and may prevent the use of the current screening tools for delirium in neurointensive care patients.
• Sleep disturbances in ICU patients are often associated with the development of ICU delirium and evaluating the time course of these conditions may reveal their possible causal relationship.

Outcomes Primary outcomes

• Development of ICU delirium Secondary outcomes
• Length of stay in ICU
• Case-fatality risk
• Post-ICU dementia (BDS, Blessed dementia scale)
• Degree of functional dependency (Barthel index)

Objectives

• To review the incidence and significant modifiable and non-modifiable predisposing and precipitating risk factors for ICU delirium and post-ICU dementia in general and neuro-intensive/critical care in adult and paediatric populations treated in health care facilities according to current recommendations for prevention of these complications (ABCDEF bundle).
• To verify optimal methods for diagnostic screening of ICU delirium: CAM-ICU (The confusion assessment method for the ICU), 4AT (Rapid clinical test for delirium detection - 4AT) and ICDSC (Intensive care delirium screening checklist) in adult populations and pCAM-ICU (paediatric confusion assessment method for the ICU), psCAM-ICU (pre-school confusion assessment method for the ICU) and CAPD (Cornell Assessment of Pediatric Delirium) in paediatric populations to screen for delirium.
• To verify optimal methods for the differential diagnosis of conditions that mimic or complicate the diagnosis of ICU delirium: NCSE, aphasia,
• To investigate associations between sleep disturbances and ICU-delirium to confirm their role in the pathophysiology of delirium.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neurointensive/neurocritical group (N-ICU)

CAM-ICU

Intervention Type: DIAGNOSTIC_TEST

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

ICDSC

Intervention Type: DIAGNOSTIC_TEST

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

4AT

Intervention Type: DIAGNOSTIC_TEST

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

MASTcz (The Mississippi Aphasia Screening Test)

Intervention Type: DIAGNOSTIC_TEST

People with aphasia will be examined by a skilled speech therapist.

EEG

Intervention Type: DIAGNOSTIC_TEST

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

Paediatric intensive/critical group (P-ICU)

p(s)CAM-ICU

Intervention Type: DIAGNOSTIC_TEST

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

CAPD

Intervention Type: DIAGNOSTIC_TEST

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

EEG

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

CAM-ICU

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

Intervention Type: DIAGNOSTIC_TEST

ICDSC

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

Intervention Type: DIAGNOSTIC_TEST

4AT

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

Intervention Type: DIAGNOSTIC_TEST

p(s)CAM-ICU

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

Intervention Type: DIAGNOSTIC_TEST

CAPD

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

Intervention Type: DIAGNOSTIC_TEST

MASTcz (The Mississippi Aphasia Screening Test)

People with aphasia will be examined by a skilled speech therapist.

Intervention Type: DIAGNOSTIC_TEST

EEG

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Motol

OTHER

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brno University Hospital

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Josef Bednařík, prof. MD, CSc.

Role: CONTACT

bednarik.josef@fnbrno.cz

532231481

Lucia Bakošová, MD

Role: CONTACT

bakosova.lucia@fnbrno.cz

532232503

Facility Contacts

Josef Bednařík, prof. MD, CSc.

Role: primary

bednarik.josef@fnbrno.cz

532231481

Other Identifiers

DELUSION-DEEP-CZ

Identifier Type: -

Identifier Source: org_study_id