UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026563 |
|---|---|
| Receipt number | R000030501 |
| Scientific Title | Prediction of respiratory parameters during mechanical ventilation using lung analysis function of three dimensional CT |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2020/03/25 11:44:41 |
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Basic information
Public title
Prediction of respiratory parameters during mechanical ventilation using lung analysis function of three dimensional CT
Acronym
Lung analysis and respiratory parameters
Scientific Title
Prediction of respiratory parameters during mechanical ventilation using lung analysis function of three dimensional CT
Scientific Title:Acronym
Lung analysis and respiratory parameters
Region
| Japan |
Condition
Condition
1) Patients who undergo general anesthesia for surgery
2) Patients who undergo lung resection
Classification by specialty
| Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between the destroyed lung volume (low attenuation volume and high attenuation volume) and respiratory parameters during mechanical ventilation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between lung analysis on CT and respiratory parameters during mechanical ventilation.
Key secondary outcomes
Cut off value of the destroyed lung volume for low oxygen saturation during mechanical 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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who undergo general anesthesia for surgery
2) Patients who undergo lung resection
Key exclusion criteria
Patients who have no CT scan which was performed in our hospital.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
569-8686
Address
Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL
072-683-1221
ane052@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
569-8686
Address
Daigaku-machi 2-7, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
ane052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Self-funding(Department of Anesthesiology, Osaka Medical College)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Osaka Medical College
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Medical COllege
Address
Daigaku-machi 2-7, Takatsuki, Osaka
Tel
+81726831221
rinri@osaka-med.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
大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030501
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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