UMIN-CTR Clinical Trial

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
Email	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
Email	ane052@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030501