UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037512 |
|---|---|
| Receipt number | R000042766 |
| Scientific Title | Influence of preoperative pulmonary function on postoperative results in cardiac surgery patients |
| Date of disclosure of the study information | 2019/07/29 |
| Last modified on | 2020/06/23 17:54:07 |
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Basic information
Public title
Influence of preoperative pulmonary function on postoperative results in cardiac surgery patients
Acronym
Lung function and postoperative results
Scientific Title
Influence of preoperative pulmonary function on postoperative results in cardiac surgery patients
Scientific Title:Acronym
Postoperative effects of preoperative pulmonary function
Region
| Japan |
Condition
Condition
cardiac disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of preoperative lung function evaluation on the surgical outcome of open heart surgery patients
Basic objectives2
Others
Basic objectives -Others
postoperative results
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day mortality
Key secondary outcomes
postoperative hospitalization, prolonged ventilation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Open heart surgery case with preoperative lung function test
Key exclusion criteria
concomitant aortic surgery
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Cardiovascular Surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
m-fujii@nms.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Fujii |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Cardiovascular Surgery
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba
TEL
0476-99-1111
Homepage URL
m-fujii@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokusoh Hospital
Address
1715 Kamagari, Inzai, Chiba
Tel
0476-99-1111
s-kikuchi@nms.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
| 2019 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://journal.hsforum.com/index.php/HSF/article/download/2791/4707
Publication of results
Published
Result
URL related to results and publications
https://journal.hsforum.com/index.php/HSF/article/download/2791/4707
Number of participants that the trial has enrolled
148
Results
The mechanical ventilation and postoperative hospital stay in the combined group was significantly longer than that in others. Patients in the restrictive group had a significantly longer postoperative ventilation or hospitalization than those in the normal group. However, there were no significant differences in the 30-day mortality rates between the groups. There also was a significant negative correlation between the percent predicted FEV1.0 and mechanical ventilation and postoperative hospitalization.
Results date posted
| 2020 | Year | 06 | Month | 23 | 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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 23 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 23 | Day |
Other
Other related information
A retrospective observational study is conducted for elective open heart surgery (except for aortic surgery) that could have undergone preoperative pulmonary function test, to investigate 30-day mortality, postoperative hospitalization, and prolonged ventilation.
Management information
Registered date
| 2019 | Year | 07 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042766
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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