DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC

Not yet recruiting

• Conditions: Delirium
• Interventions: Diagnostic Test: CAM-ICU; Diagnostic Test: pCAM-ICU

• Registration Number: NCT05841368
• Lead Sponsor: Brno University Hospital

Brief Summary

Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.

Detailed Description

All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-22
• Study First Submitted QC: 2023-04-22
• Last Update Submitted: 2023-04-22
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Study Start: 2024-01-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients in ICU settings
• in defined time interval of the study

Exclusion Criteria

• duration of ICU stay shorter than 24 hours

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult ICU patients	CAM-ICU	Adult patients in ICU setting
Pediatric ICU patients	pCAM-ICU	Pediatric patients in ICU setting

Primary Outcome Measures

Name	Time	Method
Delirium prevalence	during 30 days after study initiation in selected ICU	Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval

Secondary Outcome Measures

Name	Time	Method
28-days mortality	after patient inclusion into the study	28-days mortality will be evaluated
Delirium management	during 30 days after study initiation in selected ICU	Management of delirium will be evaluated
90-days mortality	after patient inclusion into the study	long term mortality will be evaluated
Inhospital mortality	during 30 days after study initiation in selected ICU	Inhospital mortality will be evaluated

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia