UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Lung Ventilation and Perfusion by Capnometer
Acronym	Intrabronchial Capnography
Scientific Title	Evaluation of Lung Ventilation and Perfusion by Capnometer
Scientific Title:Acronym	Intrabronchial Capnography
Region	Japan

Condition
Condition	bronchial stenosis
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the regional gas exchange by measuring carbon dioxide (CO2) concentration during bronchoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	End - tidal carbon dioxide (EtCO2) concentration before and after interventional bronchoscopy
Key secondary outcomes	Lung ventilation and perfusion status before and after interventional bronchoscopy. Lung ventilation and perfusion status at lobar bronchi during bronchoscopy.

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	For patients with bronchial stenosis or COPD. CO2 concentration was measured using a catheter at trachea, main bronchi and lobar bronchi during bronchoscopy.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Bronchoscopy is performed in patients with bronchial stenosis or COPD.
Key exclusion criteria	Patients with sever pulmonary dysfunction
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masamichi Mineshita
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Diseases, Department of Internal Medicine
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL	044-977-8111
Email	m-mine@marianna-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroki Nishine
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory Diseases, Department of Internal Medicine
Zip code
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL	044-977-8111
Homepage URL
Email	h2nishine@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
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
Address
Tel
Email

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	2013 Year 02 Month 10 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	Completed
Date of protocol fixation	2011 Year 05 Month 01 Day
Date of IRB	2011 Year 07 Month 26 Day
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 02 Month 10 Day
Last modified on	2021 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011720