UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000977 |
|---|---|
| Receipt number | R000001172 |
| Scientific Title | Non-invasive continuous cardiac output measurement using routine cardiovascular monitors |
| Date of disclosure of the study information | 2008/01/11 |
| Last modified on | 2012/07/09 16:39:34 |
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Basic information
Public title
Non-invasive continuous cardiac output measurement using routine cardiovascular monitors
Acronym
A new non-invasive continuous cardiac output monitor
Scientific Title
Non-invasive continuous cardiac output measurement using routine cardiovascular monitors
Scientific Title:Acronym
A new non-invasive continuous cardiac output monitor
Region
| Japan |
Condition
Condition
ICU patients who are treated under continuous cardiac output monitoring with PA catheter
Classification by specialty
| Cardiology | Surgery in general | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the accuracy of a new non-invasive cardiac output monitoring using ECG and SpO2 pulse wave in the ICU compared with PAcather
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with the CCO data obtained by PA catheter using correlation and difference of averages and deviation of values
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
ICU patients who are treated under the continuous cardiac output monitoring with PA catheter
Key exclusion criteria
1.Apparent arrhythmia
2.Intraaortic balloon pumping
3.Cardiac pacing
4.No indication of PA catheter
5.Rejection of agreement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morisaki, MD |
Organization
Keio University School of Medicine
Division name
Departmen of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Departmen of Anesthesiology
Zip code
Address
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Nihon Kohden
Institute
Department
Personal name
Funding Source
Organization
Nihon Kohden
Organization
Division
Category of Funding Organization
Profit 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
| 2008 | Year | 01 | Month | 11 | 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
We have obtained fairly good relationship between PA catheter data and our new non-invasive method. Anesthaia Analgesia 2012;115:82-86.
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
| 2008 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine the accuracy of a new non-invasive continuous cardiac output monitoring compared with PA catheter data
Management information
Registered date
| 2008 | Year | 01 | Month | 09 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001172
