UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048142
Receipt No. 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 2022/06/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email gomadofu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 253
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 No longer recruiting
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
2022 Year 06 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054862

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.