UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of functional residual capacity by volumetric capnography
Title of the study (Brief title)	Measurement of functional residual capacity by volumetric capnography
Region	Japan

Condition
Condition	healthy volunteer
Classification by specialty	Pneumology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess the reliabity of the functional residual capacity(FRC) mesurement using novel volumetric capnography comparied with the helium gas dilution method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FRC by using novel volumetric capnography FRC by the helium gas dilution method
Key secondary outcomes	airway dead space alveolar dead space

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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	healty volunteer
Key exclusion criteria	1.current smoker 2.upper respiratory tract infection within 2week 3.history of lung surgery 4.pregnat woman 5.obesity (BMI is over 30kg/m2) 6.those who can not obtain consent
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Araki
Organization	National Hospital Organization Nagasaki Medical Hospital
Division name	Department of Anesthesiology
Address	2-1001-1 Kubara,Oomura-shi,Nagasaki
TEL	0957523121
Email	haraki@nagasaki-mc.com

Public contact
Name of contact person	Hiroshi Araki
Organization	National Hospital Organization Nagasaki Medical Hospital
Division name	Department of Anesthesiology
Address	2-1001-1 Kubara,Oomura-shi,Nagasaki
TEL	0957523121
Homepage URL
Email	haraki@nagasaki-mc.com

Sponsor
Institute	National Hospital Organization Nagasaki Medical Hospital
Institute
Department

Funding Source
Organization	No reserch fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立病院機構　長崎医療センター（長崎県）

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Nothing

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038970