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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000034055 |
Receipt No. | 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 | 2019/09/09 |
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 |
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Condition | ||
Condition | Upper 60-year-old patients who will receive general anesthesia | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Showa University |
Institute | |
Department |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038817 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |