UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053496 |
|---|---|
| Receipt number | R000061059 |
| Scientific Title | A prospective study to investigate the utility of preoperative ICU orientation for the prevention of postoperative delirium in cardiovascular surgery |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/31 16:38:42 |
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Basic information
Public title
A prospective study to investigate the utility of preoperative ICU orientation for the prevention of postoperative delirium in cardiovascular surgery
Acronym
A prospective study to investigate the utility of preoperative ICU orientation for the prevention of postoperative delirium in cardiovascular surgery
Scientific Title
A prospective study to investigate the utility of preoperative ICU orientation for the prevention of postoperative delirium in cardiovascular surgery
Scientific Title:Acronym
A prospective study to investigate the utility of preoperative ICU orientation for the prevention of postoperative delirium in cardiovascular surgery
Region
| Japan |
Condition
Condition
Cardiac disease, Aortic disease, Delirium
Classification by specialty
| Cardiology | Vascular surgery | Psychiatry |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective, single-arm study to determine whether this orientation is effective in reducing the incidence of postoperative delirium in cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of postoperative delirium in ICU
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Preoperative orientation regarding the postoperative ICU environment and delirium
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 20 years of age or older who will be performed scheduled cardiovascular surgery at our hospital and who will be admitted to the ICU after surgery
Key exclusion criteria
Emergent surgery
Patients who aren not admitted to the ICU after surgery
Patients under 20 years old
Patients who do not accept the examination
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Nakamura |
Organization
Wamayama medical university
Division name
Cardiothoracic surgery
Zip code
641-8519
Address
811-1 Kimiidera, wakayama city, Japan
TEL
073-441-0615
m09077rn@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Nakamura |
Organization
Wakayama medical university
Division name
Cardiothoracic surgery
Zip code
641-8509
Address
811-1 Kimiidera, wakayama city, Japan
TEL
073-441-0615
Homepage URL
m09077rn@wakayama-med.ac.jp
Sponsor or person
Institute
Ryo Nakamura
Wakayama medical university, department of Cardiothoracic Surgery
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
Wakayama medical university, IRB comittee
Address
811-1, Kimiidera, Wakayama city, Wakayama prefecture, Japan kimiide
Tel
073-441-0897
wa-rinri@wakayama-med.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
| 2024 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061059
