UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037512
Receipt No. 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 (Ver. 5)

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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
Email 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
Email m-fujii@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042766