UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042884 |
|---|---|
| Receipt number | R000048946 |
| Scientific Title | A study on peak pressure of air leak test in lung surgery |
| Date of disclosure of the study information | 2021/01/02 |
| Last modified on | 2021/01/02 06:31:05 |
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Basic information
Public title
A study on peak pressure of air leak test in lung surgery
Acronym
A study on peak pressure of air leak test in lung surgery
Scientific Title
A study on peak pressure of air leak test in lung surgery
Scientific Title:Acronym
A study on peak pressure of air leak test in lung surgery
Region
| Japan |
Condition
Condition
Lung disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In lung surgery, the presence or absence of air leak is checked after lobectomy, and the pressure required for this is defined as the "leak test pressure", and a discussion of the appropriate leak test pressure should be provided.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum leak test pressure and duration of postoperative drain placement
Key secondary outcomes
Comparison of maximal leak test pressure and postoperative drain placement duration surgical technique, presence of respiratory complications, high leak test pressure group and low leak test pressure group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Respiratory surgery performed at our hospital.
Key exclusion criteria
Mediastinal tumor.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Son |
| Middle name | |
| Last name | Kyonsu |
Organization
Chiba university hospital
Division name
Anesthesiology, pain and palliative care medicine
Zip code
260-8677
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL
0432227171
ccpa0908@chiba-u.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Chikubu |
Organization
Chiba university hospital
Division name
Anesthesiology,pain and palliative care medicine
Zip code
260-8677
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL
0432227171
Homepage URL
ccpa0908@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Chiba university hospital Clinical research center
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
Tel
0432227171
ccpa0908@chiba-u.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
| 2021 | Year | 01 | Month | 02 | 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
28
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective research
Management information
Registered date
| 2021 | Year | 01 | Month | 02 | Day |
Last modified on
| 2021 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048946
