UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013984 |
|---|---|
| Receipt number | R000016269 |
| Scientific Title | Evaluation of the accuracy of non-invasive cardiac output monitoring after cardiovascular surgery |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2019/02/01 15:19:17 |
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Basic information
Public title
Evaluation of the accuracy of non-invasive cardiac output monitoring after cardiovascular surgery
Acronym
Evaluation of non-invasive cardiac output monitoring
Scientific Title
Evaluation of the accuracy of non-invasive cardiac output monitoring after cardiovascular surgery
Scientific Title:Acronym
Evaluation of non-invasive cardiac output monitoring
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and the accuracy of cardiac output and stroke volume variation monitored by esCCO (estimated Continuous Cardiac Output), which calculate these parameters noninvasively by pulse oximetry and electrocardiogram, as compared with pulmonary artery catheter and arterial pressure based cardiac output monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the chronological correlation between esCCO and pumonary artery catheter/arterial pressure based cardiac output monitoring regarding coadiac output and stroke vovume variation.
Key secondary outcomes
Base
Study type
Interventional
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
cardiac output monitoring by pulse oxymetry
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 cardiovascular surgery
Key exclusion criteria
patients less than 20 years old
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morisaki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
morisaki@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon Kohden Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 15 | 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
| 2014 | Year | 05 | Month | 17 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016269
