UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046023 |
|---|---|
| Receipt number | R000052532 |
| Scientific Title | Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2021/11/09 21:36:11 |
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Basic information
Public title
Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Acronym
Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Scientific Title
Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Scientific Title:Acronym
Relationship between the need for preoperative respiratory function testing and postoperative pulmonary complications
Region
| Japan |
Condition
Condition
Diseases for which surgery is indicated
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Oto-rhino-laryngology | Orthopedics |
| Urology | Anesthesiology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With COVID19, preoperative respiratory function tests will not be performed. We will examine whether the respiratory function test, which has been performed as a preoperative test, is necessary for perioperative management and is useful for predicting postoperative pulmonary complications.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prediction of postoperative pulmonary complications
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing respiratory function tests undergoing surgery
Key exclusion criteria
Postoperative respiratory management cases
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St.Marianna University school of Medicine
Division name
Anesthesiology
Zip code
2168511
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St Marianna university school of medicine St Marianna university school of mediciney yokohama city s
Division name
Anesthesiology
Zip code
2168511
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University school of Medicine
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
St. Marianna University school of Medicine
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
Tel
0449778111
http://marianna-net.marianna-u.ac.jp/kenkyusienbu/seimeirinri/IRB. htm
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
聖マリアンナ医科大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2021 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052532
