UMIN-CTR Clinical Trial

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 Nagahide Middle name Last name Yoshida
Organization	Saiseikai Maebashi Hospital
Division name	Anesthesiology
Zip code	371-0821
Address	564-1 kamishinden-machi Maebashi Gunma.
TEL	027-252-6011
Email	totemkopf@hotmail.co.jp

Public contact
Name of contact person	1st name Nagahide Middle name Last name Yoshida
Organization	Saiseikai Maebashi Hospital
Division name	Anesthesiology
Zip code	371-0821
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	saiseikai-maebashi hospital
Address	mamishindenn maebashi gunma pft 564-1
Tel	027-252-6011
Email	n-yoshida@maebashi.saiseikai.or.jp

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	Terminated
Date of protocol fixation	2016 Year 01 Month 10 Day
Date of IRB	2016 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 31 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2019 Year 11 Month 22 Day

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