UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048142 |
|---|---|
| Receipt number | R000054862 |
| Scientific Title | Retrospective observational study examining the impact of preoperative nurse-led orientation program on postoperative delirium after cardiovascular surgery |
| Date of disclosure of the study information | 2022/06/23 |
| Last modified on | 2023/05/18 10:20:50 |
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Basic information
Public title
Retrospective observational study examining the impact of preoperative nurse-led orientation program on postoperative delirium after cardiovascular surgery
Acronym
preoperative nurse-led orientation program and postoperative delirium
Scientific Title
Retrospective observational study examining the impact of preoperative nurse-led orientation program on postoperative delirium after cardiovascular surgery
Scientific Title:Acronym
preoperative nurse-led orientation program and postoperative delirium
Region
| Japan |
Condition
Condition
Planned cardiovascular surgery patients admitted to ICU
Classification by specialty
| Surgery in general | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate whether nurse-led orientation program could reduce the delirium during intensive care unit (ICU) after cardiovascular surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative delirium defined as at least one positive CAM-ICU result during their ICU stay
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients underwent planned cardiovascular surgery admitted to our ICU
Key exclusion criteria
We excluded patients who received emergent surgery, or who were not admitted to the ICU.
Target sample size
253
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
TEL
0734472300
gomadofu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
641-0012
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
TEL
0734472300
Homepage URL
gomadofu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama-city, Wakayama, Japan
Tel
0734472300
gomadofu@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
| 2022 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-023-00666-3
Number of participants that the trial has enrolled
253
Results
Above URL will show the results.
Results date posted
| 2023 | Year | 05 | Month | 18 | Day |
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
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054862
