UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034055 |
|---|---|
| Receipt number | R000038817 |
| Scientific Title | Peri-operative cognitive assessment using "Cognitive Assessment for Dementia iPad version 2 (CADi 2). |
| Date of disclosure of the study information | 2018/09/06 |
| Last modified on | 2022/09/09 10:17:08 |
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Basic information
Public title
Peri-operative cognitive assessment using "Cognitive Assessment for Dementia iPad version 2 (CADi 2).
Acronym
Peri-operative cognitive assessment using "Cognitive Assessment for Dementia iPad version 2 (CADi 2).
Scientific Title
Peri-operative cognitive assessment using "Cognitive Assessment for Dementia iPad version 2 (CADi 2).
Scientific Title:Acronym
Peri-operative cognitive assessment using "Cognitive Assessment for Dementia iPad version 2 (CADi 2).
Region
| Japan |
Condition
Condition
Upper 60-year-old patients who will receive general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
CADi2 is a computerized neurocognitive test. This study aim to investigate the changes between preoperative and postoperative (after 1 week) CADi2 scores and response time. Secondary outcome is to investigate risk factors of post-operative cognitive dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of CADi2 score and response time between preoperative and postoperative (1week after operation).
Key secondary outcomes
To investigate risk factors of post-operative cognitive dysfunction.
Anesthesia record: Operation time, anesthesia time, anesthesia prosedure, vital signs, Patient State Index( PSI)
The incidence of postoperative delirium, pain level (NRS)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged over 60 and scheduled for surgery under general anesthesia.
Patients who give written informed consent to participate in the study
Key exclusion criteria
Patients who have serious audio-visual obstacle that affected communication.
Patients who underwent neurosurgery.
Patients who were judged to be inappropriate as subjects by the study investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Hosokawa |
Organization
Showa University
Division name
Department of Anesthesia
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
fabius.tiro@gmail.com
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Hosokawa |
Organization
Showa University
Division name
Department of Anesthesiology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8575
Homepage URL
fabius.tiro@gmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Not appricable
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
Ethics comittee specializing in human subgects reserch at the Showa University.
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
gakuji@ofc.showa-u.ac.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
昭和大学病院、昭和大学附属東病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients information: age, gender, height/weight, BSA, BMI, diagnosis, operation, ASA-PS, blood test, drug, past history, FRAIL score, education level
Anesthesia record: procedure, drug, vital signs, PSI
CADi2 score and response time (preoperative, 1 week after operation)
Medical record: delirium, post-operative pain (NRS)
Management information
Registered date
| 2018 | Year | 09 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038817
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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