eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan

eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan - eDIS-ICU: An international validation study to improve accuracy of screening for delirium in the ICU - A sub-analysis using ICDSC data from two institutions in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047064

Enrollment

220

Registered

2022-03-10

Start date

2022-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delirium

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients expected to stay in the ICU for more than 24 hours upon admission. At least 18 years of age. Patients must be able to consistently communicate "Yes" and "No" verbally and non-verbally. Able to obtain consent for the study from the patient and a surrogate.

Exclusion criteria

Exclusion criteria: Patients with severe cognitive impairment that interferes with their ability to understand and answer questions. Patients who do not understand Japanese and are unable to comprehend the research consent process or evaluation instructions. Patients who have visual or hearing impairment and cannot hear verbal evaluation instructions or see the application screen.

Design outcomes

Primary

Measure	Time frame
- Sensitivity of the eDIS-ICU compared to the ICDSC to the DSM-V (gold standard).	—

Secondary

Measure	Time frame
Prevalence of delirium during the observation period. concordance of delirium prevalence between eDIS-ICU, CAM-ICU and DSM-V. Reliability is defined as a Kappa coefficient greater than or equal to 0.6. Other measures of diagnostic accuracy (specificity, PPV, NPV, diagnostic odds). time taken (in seconds) to administer the eDIS-ICU and CAM-ICU. number of occasions in which the eDIS-ICU could be completed compared to the CAM-ICU.	—

Measure

Time frame

Prevalence of delirium during the observation period. concordance of delirium prevalence between eDIS-ICU, CAM-ICU and DSM-V. Reliability is defined as a Kappa coefficient greater than or equal to 0.6. Other measures of diagnostic accuracy (specificity, PPV, NPV, diagnostic odds). time taken (in seconds) to administer the eDIS-ICU and CAM-ICU. number of occasions in which the eDIS-ICU could be completed compared to the CAM-ICU.

—

Countries

Japan,Australia,Europe

Contacts

Public ContactYuji Koga

KAWASAKI MEDICAL SCHOOL HOSPITAL Department of Nursing

yuji-koga@umin.ac.jp0864621111

Outcome results