UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009960
Receipt number R000011663
Scientific Title A study of the efficacy of central venous oxygen saturation (ScvO2) measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac) as predictors of perioperative oxygen supply-demand balance. (An observational study)
Date of disclosure of the study information 2013/03/01
Last modified on 2017/04/28 03:18:17

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Basic information

Public title

A study of the efficacy of central venous oxygen saturation (ScvO2) measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac) as predictors of perioperative oxygen supply-demand balance. (An observational study)

Acronym

A study of the efficacy of central venous oxygen saturation (ScvO2) and cardiac output measured by arterial pulse contour analysis as predictors of perioperative oxygen supply-demand balance. (An observational study)

Scientific Title

A study of the efficacy of central venous oxygen saturation (ScvO2) measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac) as predictors of perioperative oxygen supply-demand balance. (An observational study)

Scientific Title:Acronym

A study of the efficacy of central venous oxygen saturation (ScvO2) and cardiac output measured by arterial pulse contour analysis as predictors of perioperative oxygen supply-demand balance. (An observational study)

Region

Japan


Condition

Condition

Surgical patients

Classification by specialty

Surgery in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of ScvO2 and cardiac output measured by arterial pulse contour analysis as predictors of perioperative oxygen supply-demand balance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Perioperative change of lactate/organ function. The parameters of organ function consist of the following: AST, ALT, bilirubin, BUN, creatinine, PaO2, P/F ratio, and duration of mechanical ventilation.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Surgical patients, who require monitoring of intra-arterial blood pressure and central venous pressure, undergoing general anesthesia

Key exclusion criteria

Contraindication for a central venous catheter placement

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Imabayashi

Organization

Graduate School of Medical and Dental Sciences, Kagoshima University

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code


Address

8-35-1 Sakuragaoka, Kagoshima, Kagoshima

TEL

099-275-5430

Email

ii1111@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Imabayashi

Organization

Kagoshima University Medical and Dental Hospital

Division name

Department of Anesthesiology

Zip code


Address

8-35-1 Sakuragaoka, Kagoshima, Kagoshima

TEL

099-275-5430

Homepage URL


Email

ii1111@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 03 Month 01 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

2013 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 03 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

We measure the variation of ScvO2 measured by PreSep/PediaSat and cardiac output measured by arterial pulse contour analysis (LiDCOrapid/FloTrac). The correlation between the variations of ScvO2/cardiac output and lactate/organ function is examined. The parameters of organ function consist of the following: AST, ALT, bilirubin, BUN, creatinine, PaO2, P/F ratio, and duration of mechanical ventilation.
This study is a prospective study.


Management information

Registered date

2013 Year 02 Month 05 Day

Last modified on

2017 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011663


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name