UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011768 |
|---|---|
| Receipt number | R000013760 |
| Scientific Title | Evaluation of the efficacy of central venous oxygen saturation measured by PreSep Central Venous Oximetry Catheter |
| Date of disclosure of the study information | 2013/09/14 |
| Last modified on | 2013/09/14 16:05:35 |
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Basic information
Public title
Evaluation of the efficacy of central venous oxygen saturation measured by PreSep Central Venous Oximetry Catheter
Acronym
Evaluation of the efficacy of central venous oxygen saturation measured by PreSep Central Venous Oximetry Catheter
Scientific Title
Evaluation of the efficacy of central venous oxygen saturation measured by PreSep Central Venous Oximetry Catheter
Scientific Title:Acronym
Evaluation of the efficacy of central venous oxygen saturation measured by PreSep Central Venous Oximetry Catheter
Region
| Japan |
Condition
Condition
patients undergoing surgery with general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to estimate the efficacy of ScvO2 mesured by PreSep Central Venous Oximetry Catheter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between ScvO2 from blood gas analysis and PreSep Central Venous Oximetry Catheter
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
central venous oxygen saturation
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
Patients undergoing general anesthesia with monitoring of central venous oxygen saturation
Key exclusion criteria
difficulty in central venous catheterisation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Araki |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
Address
Namiki 3-2, Tokorozawa-city, Saitama
TEL
04-2995-1211
dr23043@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Araki |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
Address
Namiki 3-2, Tokorozawa-city, Saitama
TEL
04-2995-1211
Homepage URL
dr23043@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College and Department Funding
Organization
Division
Category of Funding Organization
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 | 09 | Month | 14 | 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
| 2010 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013760
