UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017616 |
|---|---|
| Receipt number | R000020401 |
| Scientific Title | Comparison of breath carbon dioxide concentration and blood carbon dioxide concentration value using the oxygen mask with main stream system CO2 sensor kit in children |
| Date of disclosure of the study information | 2015/05/19 |
| Last modified on | 2019/04/25 13:10:39 |
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Basic information
Public title
Comparison of breath carbon dioxide concentration and blood carbon dioxide concentration value using the oxygen mask with main stream system CO2 sensor kit in children
Acronym
Comparison of breath carbon dioxide concentration and blood carbon dioxide concentration value using the oxygen mask with main stream system CO2 sensor kit in children
Scientific Title
Comparison of breath carbon dioxide concentration and blood carbon dioxide concentration value using the oxygen mask with main stream system CO2 sensor kit in children
Scientific Title:Acronym
Comparison of breath carbon dioxide concentration and blood carbon dioxide concentration value using the oxygen mask with main stream system CO2 sensor kit in children
Region
| Japan |
Condition
Condition
Pediatric patients although performing invasive arterial pressure measurement and not tracheal intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Exhaled carbon dioxide concentration level and blood carbon dioxide concentration value of a non-tracheal intubation patient using the main stream method CO2 sensor kit to compare study in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the breath carbon dioxide concentration level and blood carbon dioxide concentration value
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To use the oxygen mask with main stream system CO2 sensor kit to pediatric patients
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Non-tracheal intubation patient in need of oxygen administration is doing the invasive arterial pressure measured in less than 15 years (noninvasive positive pressure ventilation patients are excluded).
Key exclusion criteria
Patients mask wearing is deemed to be inappropriate in such as facial surgery, Patients unable to mount the nasal cannula, Patient consent can not be obtained
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | masateru |
| Middle name | |
| Last name | kumemura |
Organization
Jikei Medical University Hospital
Division name
Anesthesiology
Zip code
1050003
Address
3-19-18 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
madmoon1109@gmail.com
Public contact
Name of contact person
| 1st name | masateru |
| Middle name | |
| Last name | kumemura |
Organization
Jikei Medical University Hospital
Division name
Anesthesiology
Zip code
1050003
Address
3-19-18 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111(4040)
Homepage URL
madmoon1109@gmail.com
Sponsor or person
Institute
Jikei Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Jikei Medical University Hospital
Address
3-19-18 Nishishimbashi, Minato-ku, Tokyo
Tel
03-3433-1111(4040)
madmoon1109@gmail.com
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
| 2015 | Year | 05 | Month | 19 | 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
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020401
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
