UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024380 |
|---|---|
| Receipt number | R000028030 |
| Scientific Title | Responsive comparison of the ventilatory frequency monitor for the change of the ventilatory frequency |
| Date of disclosure of the study information | 2016/10/12 |
| Last modified on | 2018/10/14 13:43:57 |
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Basic information
Public title
Responsive comparison of the ventilatory frequency monitor for the change of the ventilatory frequency
Acronym
Responsive comparison of the ventilatory frequency monitor for the change of the ventilatory frequency
Scientific Title
Responsive comparison of the ventilatory frequency monitor for the change of the ventilatory frequency
Scientific Title:Acronym
Responsive comparison of the ventilatory frequency monitor for the change of the ventilatory frequency
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the measured value with the ventilatory frequency monitor can follow a real change in how much time, or to inspect whether you can measure the change exactly when we changed ventilatory frequency for healthy adult volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monitor measuring carbon dioxide exhaling, the monitor which I affix a sound sensor to a neck, and measure ventilatory frequency, ventilatory frequency measured with a monitor calculating ventilatory frequency by a breathing-related change of the pulse oximetry
Key secondary outcomes
Monitor measuring carbon dioxide exhaling, the monitor which I affix a sound sensor to a neck, and measure ventilatory frequency, ventilatory frequency measured with a monitor calculating ventilatory frequency by a breathing-related change of end tidal carbon dioxide concentration,peripheral arterial blood oxygen saturation,pulse rate,tip perfusion index
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
| Behavior,custom |
Interventions/Control_1
We measure it with rest face up position and stop breathing as much as possible next. We let you do rest breathing again and let you perform around 30 times of tachypnea as much as possible. We measure this repeatedly three times each.
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
Healthy adult volunteer
Key exclusion criteria
It is the person with the disease to the vital organs such as respiratory organs, the circulatory organ
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Murakawa |
Organization
Fukushima medical university hospital
Division name
Department of Anesthesiology
Zip code
Address
1,hikarigaoka,fukushima,fukushima
TEL
024-547-1111
murakawa@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Honda |
Organization
Fukushima Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
1,hikarigaoka,fukushima,fukushima
TEL
024-547-1111
Homepage URL
j.honda1984@gmail.com
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 12 | 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
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 12 | 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
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028030
