UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028685 |
|---|---|
| Receipt number | 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 15:33:06 |
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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
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
keishii1101@gmail.com
Sponsor or person
Institute
Fukuyama City Hospital
Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032816
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