UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	Enrolling by invitation
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	2019 Year 09 Month 09 Day

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

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