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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024909
Receipt No. R000028591
Scientific Title Understanding a-ET difference of CO2 partial pressure by novel volumetric capnography
Date of disclosure of the study information 2016/11/21
Last modified on 2017/11/21

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Basic information
Public title Understanding a-ET difference of CO2 partial pressure by novel volumetric capnography
Acronym Novel Interpretation of a-ET Difference of CO2 partial Pressure by Volumetric Capnography
Scientific Title Understanding a-ET difference of CO2 partial pressure by novel volumetric capnography
Scientific Title:Acronym Novel Interpretation of a-ET Difference of CO2 partial Pressure by Volumetric Capnography
Region
Japan

Condition
Condition patient of elective four limbs surgery received general anesthesia with controled artificial ventilation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 under controled artificial ventilation condition,using volumetric capnpgram,explaning arterial and endidal CO2 pertial pressure difference by dead space and shunt fffect.
Basic objectives2 Others
Basic objectives -Others Finding a rerationship between ventilation/perfusion mismatch and shunt effects.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes under the condition of artificial ventilation,arterial-endtidal CO2 precial pressure difference will be explaned by dead space,shant effect obtained from volumetric capnoglafy analysis.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria patients who is elective surgery patients for under general anaesthesia with artificial controred ventilation and
phisical status of ASA class 1 or 2 patient.

Key exclusion criteria the pateints who have severe respiratpry or circuratory disorder on pre-oprating period.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagahide Yoshida
Organization Saiseikai Maebashi Hospital
Division name Anesthesiology
Zip code
Address 564-1 kamishinden-machi Maebashi Gunma.
TEL 027-252-6011
Email totemkopf@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nagahide Yoshida
Organization Saiseikai Maebashi Hospital
Division name Anesthesiology
Zip code
Address 564-1 kamishinden-machi Maebashi Gunma
TEL 027-252-6011
Homepage URL
Email totemkopf@hotmail.co.jp

Sponsor
Institute Saiseikai Maaebashi hospital Department
of Anesthesiology
Institute
Department

Funding Source
Organization Saiseikai Maaebashi hospital Department
of Anesthesiology
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 済生会前橋病院(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 21 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 Enrolling by invitation
Date of protocol fixation
2016 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Using volumetric capnography Analisis,interpretation the mechanism of difference of arterial-endtidal Co2 pretial pressure.

Management information
Registered date
2016 Year 11 Month 19 Day
Last modified on
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028591

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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