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
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
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
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
