UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017616
Receipt No. 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

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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
Email 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
Email madmoon1109@gmail.com

Sponsor
Institute Jikei Medical University Hospital
Institute
Department

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)
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020401

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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