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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006867
Receipt No. R000004796
Scientific Title The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol
Date of disclosure of the study information 2011/12/10
Last modified on 2014/07/09

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Basic information
Public title The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol
Acronym The study of ventilatory response to hypercapnia by the rebreathing methods with new protocol
Scientific Title The study of ventilatory response to hypercapnia by the rebreathing methods with the new insturuments and protocol
Scientific Title:Acronym The study of ventilatory response to hypercapnia by the rebreathing methods with new protocol
Region
Japan

Condition
Condition no disease
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical validity about the method of measurement that use a new rebreathing instrument,and to investigate the ventilatory response to carbon dioxide,comparing the mixture gas of 7% CO2 and 93% oxygen with 100% oxygen.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Minute ventilation
Key secondary outcomes

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 Prevention
Type of intervention
Device,equipment Other
Interventions/Control_1 To make rebreathe initial mixture gas, 7% carbon dioxide and 93% oxigen,or 100% oxigen.
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
Key inclusion criteria healthy men
Key exclusion criteria patients with pulmonary disease,neuromuscular disease,heart disease,cerebrovascular diseiase
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroka Hashimoto
Organization School of Medicine,Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi,Shinjuku-ku,Tokyo
TEL 08067424594
Email hokulani.h@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroka Hashimoto
Organization School of Medicine,Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi,Shinjuku-ku,Tokyo
TEL 0333531211
Homepage URL
Email hokulani.h@gmail.com

Sponsor
Institute School of Medicine,Keio University
Institute
Department

Funding Source
Organization Department of Anesthesiology,School of Medicine,Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Jpapn

Other related organizations
Co-sponsor Nihon Kohden Corporation
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 慶應義塾大学病院(東京都)、日本光電株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 12 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
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 09 Day
Last modified on
2014 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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