UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025063
Receipt number R000028809
Scientific Title The contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia
Date of disclosure of the study information 2016/11/30
Last modified on 2016/11/30 02:10:55

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Basic information

Public title

The contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia

Acronym

The contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia

Scientific Title

The contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia

Scientific Title:Acronym

The contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia

Region

Japan


Condition

Condition

a patient undergoing surgery with general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find out the contributing factors to deviation between end tidal carbon dioxide concentrations and partial pressure of carbon dioxide in arterial blood in controlled ventilation under general anesthesia.

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

delta CO2 ratio

Key secondary outcomes

age, BMI, smoking, forced expiratory volume in 1 second as percent of FVC


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

In order to examine and research the contributing factors to deviation between EtCO2 and PaCO2, We observed EtCO2 and PaCO2 immediately before start of surgery in patient who scheduled surgery. We selected the surgery in supine position.

Key exclusion criteria

We eliminate a patient who have a cardiac disorder or dyspnea worse than Huge-Hones 2.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaya Matsuyama

Organization

Red Cross Otsu hospital

Division name

Anesthesiology

Zip code


Address

1-1-35 Nagara Otsu city Shiga Japan

TEL

077-522-4131

Email

jinji@otsu.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaya Matsuyama

Organization

Red Cross Otsu hospital

Division name

Anesthesiology

Zip code


Address

1-1-35 Nagara Otsu city Shiga Japan

TEL

077-522-4131

Homepage URL


Email

jinji@otsu.jrc.or.jp


Sponsor or person

Institute

Red Cross Otsu hospita

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


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



Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 30 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 09 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In order to examine and research the contributing factors to deviation between EtCO2 and PaCO2, We observed EtCO2 and PaCO2 immediately before start of surgery in patient who scheduled surgery. We selected the surgery in supine position. We eliminate a patient who have a cardiac disorder or dyspnea worse than Huge-Hones 2. We used multi-regression analysis by Stata.Dependent variable is delta CO2 ratio. Explanatory variable is age, BMI, smoking and forced expiratory volume in 1 second as percent of FVC.


Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2016 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028809


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name