UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032846 |
|---|---|
| Receipt number | R000037460 |
| Scientific Title | An intervention study of measuring intrathoracic pressure for pneumothorax to decide the necessity of drainage |
| Date of disclosure of the study information | 2018/06/02 |
| Last modified on | 2019/12/03 14:59:41 |
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Basic information
Public title
An intervention study of measuring intrathoracic pressure for pneumothorax to decide the necessity of drainage
Acronym
An intervention study of measuring intrathoracic pressure for pneumothorax to decide the necessity of drainage
Scientific Title
An intervention study of measuring intrathoracic pressure for pneumothorax to decide the necessity of drainage
Scientific Title:Acronym
An intervention study of measuring intrathoracic pressure for pneumothorax to decide the necessity of drainage
Region
| Japan |
Condition
Condition
pneumothorax
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
decide the necessity of drainage by measuring intrathoracic pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
intrathoracic pressure
Key secondary outcomes
improvement of respiratory failure, stop of air leak, recurrence of pneumothorax
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Measur the intrapleural pressure and decide the therapeutic strategy; aspiration, drainage, or no removal of intrapleural air.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. moderate or high degree of pneumothorax
2. Patients obtained consent
Key exclusion criteria
1. low degree of pneumothorax
2. bilateral pneumothorax
3. Patients who cannot express informed conset Bilateral pneumothorax
4. Patients who have any reason not suitable for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirayuki |
| Middle name | |
| Last name | Kaneda |
Organization
Kansai Medical University Medical Center
Division name
Division of Thoracic Surgery
Zip code
570-8507
Address
10-15 Fumizonocho, Moriguchishi, Osaka, 570-8507 Japan.
TEL
06-6992-1001
kanedah@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hirayuki |
| Middle name | |
| Last name | Kaneda |
Organization
Kansai Medical University Medical Center
Division name
Division of Thoracic Surgery
Zip code
570-8507
Address
10-15 Fumizonocho, Moriguchishi, Osaka, 570-8507 Japan.
TEL
06-6992-1001
Homepage URL
kanedah@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Surgery, Kansai 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
Kansai Medical University Medical Center
Address
10-15 Fumizonocho, Moriguchishi, Osaka, 570-8507 Japan.
Tel
06-6992-1001
kanedah@takii.kmu.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
| 2018 | Year | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037460
