UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Acronym	Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Scientific Title	Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Scientific Title:Acronym	Evaluation of the minimum pressure and volume in the bronchial cuff during one lung ventilation
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The main object is to investigate the minimum bronchial cuff and volume during one lung ventilation. The second object is to examine the relation between the bronchial diameter and cuff volume.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Whether the operated lung is collapsed sufficiently
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The intra bronchial cuff pressure is determined by a cuff pressure regulator at 20cmH2O.
Interventions/Control_2	The volume of the intra bronchial cuff is determined by the capnometer.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	ASA physical status 1-2 20 years old or older agreed to participate in the study and signed informed consent form
Key exclusion criteria	Patients with severe cerebra-vascular disease,coronary heart disease or respiratory failure
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Yamada
Organization	Gifu University Graduate School of Medicine
Division name	Anesthesiology and Pain Medicine
Zip code	5011194
Address	1-1 Yanagido, Gifu City, Gifu
TEL	058-230-6404
Email	y-comet@wg7.so-net.ne.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Yamada
Organization	Gifu University Graduate School of Medicine
Division name	Anesthesiology and Pain Medicine
Zip code	5011194
Address	1-1 Yanagido, Gifu City, Gifu
TEL	058-230-6404
Homepage URL
Email	y-comet@wg7.so-net.ne.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

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	Gifu University Graduate School of Medicine
Address	1-1 Yanagido, Gifu City, Gifu
Tel	058-230-6000
Email	rinri@gifu-u.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	2016 Year 11 Month 17 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	64
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	2016 Year 11 Month 17 Day
Date of IRB	2016 Year 05 Month 06 Day
Anticipated trial start date	2016 Year 11 Month 18 Day
Last follow-up date	2021 Year 05 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 17 Day
Last modified on	2021 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028633