UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024909
Receipt number 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 2019/11/22 10:41:55

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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 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 or person

Institute

Saiseikai Maaebashi hospital Department
of Anesthesiology

Institute

Department

Personal name



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

Value
https://center6.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