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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024380
Receipt No. 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

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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
Email 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
Email j.honda1984@gmail.com

Sponsor
Institute Fukushima Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028030

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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