UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010921 |
|---|---|
| Receipt number | R000012779 |
| Scientific Title | Non-invasive estimation of cardiac output by plethysmographic signal |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2021/07/13 09:32:15 |
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Basic information
Public title
Non-invasive estimation of cardiac output by plethysmographic signal
Acronym
Non-invasive estimation of cardiac output by plethysmographic signal
Scientific Title
Non-invasive estimation of cardiac output by plethysmographic signal
Scientific Title:Acronym
Non-invasive estimation of cardiac output by plethysmographic signal
Region
| Japan |
Condition
Condition
Gastrointestinal cancer surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-invasive estimation of cardiac output by plethysmographic signal
Basic objectives2
Others
Basic objectives -Others
Evaluation of accuracy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy of estimated cardiac output compared with measured cardiac output.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective gastrointestinal cancer surgery with lapatoromy.
Patients who is indicated intraoperative invasive arterial pressure monitoring.
Key exclusion criteria
Patients who have known conditions that may negatively affect the accuracy of cardiac output measurement with pulse contour method.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6, Ohashi, Meguro, Tokyo
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6, Ohashi, Meguro, Tokyo
TEL
03-3568-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Ohashi Medical Center, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics comittee, Toho Unviersity Ohashi Medical Center
Address
2-22-36, Ohashi, Meguro, Tokyo
Tel
03-3468-1251
secretary@oha.toho-u.ac.jp
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
東邦大学医療センター大橋病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | 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
42
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under data analysis
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
| 2013 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Analysis of accuracy
Management information
Registered date
| 2013 | Year | 06 | Month | 10 | Day |
Last modified on
| 2021 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012779
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
