UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006867 |
|---|---|
| Receipt number | 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 15:30:58 |
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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
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
hokulani.h@gmail.com
Sponsor or person
Institute
School of Medicine,Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004796
