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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028685
Receipt No. R000032816
Scientific Title The effectiveness of a delirium assessment method that combining ICDSC & CAM-ICU
Date of disclosure of the study information 2017/08/16
Last modified on 2019/12/03

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Basic information
Public title The effectiveness of a delirium assessment method that combining ICDSC & CAM-ICU
Acronym Combine ICDSC & CAM-ICU
Scientific Title The effectiveness of a delirium assessment method that combining ICDSC & CAM-ICU
Scientific Title:Acronym Combine ICDSC & CAM-ICU
Region
Japan

Condition
Condition Critically Ill Patients in Intensive Care Unit
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have started a new method that combining Intensive Care Delirium Screening Checklist & Confusion Assessment Method for the ICU. In this study, the effectiveness of this new method is evaluated by calculating sensitivity and specificity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome of this study is to calculate sensitivity and specificity of our new method combining ICDSC & CAM-ICU. The intensive care physician diagnoses the patient's delirium using Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and uses this result to calculate them.
Key secondary outcomes The procedure for combining ICDSC & CAM-ICU;
Assess all patients staying at ICU using ICDSC at least every 8 hours. If the patient's ICDSC score is 0, evaluate as "not delirium" and complete the procedure. If a nurse gives a patient an ICDSC score of 1 or more, these patients will be evaluate from "Feature 2: Inattention" using CAM-ICU as appropriate until ICDSC score become zero. Regardless of ICDSC values, patients suspected of delirium are evaluated using CAM-ICU.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All of the patients admitted to our ICU from August 2016 to January 2017.
Key exclusion criteria We do not use datasets that do not contain all the data.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kenzo
Middle name
Last name Ishii
Organization Fukuyama City Hospital
Division name Department of Anesthesiology, Intensive care unit
Zip code 721-8511
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
TEL 084-941-5151
Email keishii1101@gmail.com

Public contact
Name of contact person
1st name Kenzo
Middle name
Last name Ishii
Organization Fukuyama City Hospital
Division name Department of Anesthesiology, Intensive care unit
Zip code 721-8511
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
TEL 084-941-5151
Homepage URL
Email keishii1101@gmail.com

Sponsor
Institute Fukuyama City Hospital
Department of Anesthesiology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Fukuyama City Hospital
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
Tel 084-941-5151
Email shimin-byouin@city.fukuyama.hiroshima.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 16 Day

Related information
URL releasing protocol Unpublished
Publication of results Partially published

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 572
Results
The delirium assessment was conducted 4092 times in total. Of these assessments, 854 times without data loss were used for analysis. Specificity did not change with ICDSC alone (96.4%) and our new method (96.0%), but Sensitivity increased from 50.8% (ICDSC alone) to 65.4% (combining ICDSC and CAM-ICU).
Results date posted
2019 Year 12 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
During study period, 572 cases were admitted in our IUC. Their Baseline characteristics were as follows: mean age 69.3 years old, male 64.5%, postoperative ICU admission 85.8%, mechanical ventilation 16%, mean APACHE2 score at ICU admission was 14.8, and mean SOFA score at ICU admission was 2.67.
Participant flow
Assess all patients staying at ICU using ICDSC at least every 8 hours.If the patient's ICDSC score is 0, evaluate as "not delirium" and complete the procedure.If a nurse gives a patient an ICDSC score of 1 or more, these patients will be evaluated from "Feature 2; Inattention" using CAM-ICU as appropriate until ICDSC score become zero.Regardless of ICDSC values, patients suspected of delirium are evaluated using CAM-ICU.
Adverse events
None
Outcome measures
To calculate sensitivity and specificity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 07 Month 31 Day
Date of IRB
2016 Year 07 Month 31 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 02 Month 28 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information Data collection has been completed.
It is currently under analysis.
Some of results have been announced.

Management information
Registered date
2017 Year 08 Month 16 Day
Last modified on
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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