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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009960
Receipt No. 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

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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
Institute Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department

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
URL(English) https://upload.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


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