UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057459 |
|---|---|
| Receipt number | R000064273 |
| Scientific Title | A prospective observational study investigating the noise pareidolia test for predicting delirium following major cardiovascular surgery |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2026/02/15 22:18:21 |
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Basic information
Public title
A prospective observational study investigating the noise pareidolia test for predicting delirium following major cardiovascular surgery
Acronym
A prospective observational study investigating the noise pareidolia test for predicting delirium following major cardiovascular surgery
Scientific Title
A prospective observational study investigating the noise pareidolia test for predicting delirium following major cardiovascular surgery
Scientific Title:Acronym
A prospective observational study investigating the noise pareidolia test for predicting delirium following major cardiovascular surgery
Region
| Japan |
Condition
Condition
Major cardiovascular surgery
Classification by specialty
| Vascular surgery | Psychiatry | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of the noise pareidolia test for predicting delirium following major cardiovascular surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative delirium. CAM_ICU (Confusion assessment method for the ICU).
Key secondary outcomes
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
(1)Patients scheduled to undergo elective major cardiovascular surgery
(2)Congenital open-heart surgery, valve replacement surgery, coronary artery bypass grafting (CABG), or Bentall operation, performed via median sternotomy or minimally invasive cardiac surgery (MICS)
(3)Aged 60 years or older at the time of enrollment
(4)Patients who have provided written informed consent
Key exclusion criteria
(1)Cognitive impairment that prevents proper understanding of the test instructions
(2)Visual or hearing impairments that inability to perform the Noise Pareidolia Test (NPT)
(3)Language impairments that interfere with task performance
(4)Physical or psychological conditions that pose a high risk for conducting the NPT
(5)Delirium present before the administration of the NPT
(6)Reoperation shortly after the surgery
(8)Occurrence of stroke immediately after surgery
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
980-0872
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
0227177353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Soma |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
980-0872
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
0227177353
Homepage URL
shouta.souma.a6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku university
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 Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-cho, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064273
