UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030441 |
|---|---|
| Receipt number | R000034756 |
| Scientific Title | Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2019/05/26 22:13:28 |
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Basic information
Public title
Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Acronym
Non-invasive continuous cardiac monitoring comparison
Scientific Title
Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Scientific Title:Acronym
Non-invasive continuous cardiac monitoring comparison
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of non-invasive cardiac output monitoring during thoracic aortic aneurysm surgery and post-cardiac surgery state in ICU
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation the accuracy and trending ability of CCO, APCO, esCCO
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
Inclusion criteria is patients undergoing elective thoracic aortic aneurysm surgery performing PAC and APCO monitoring, age>20years old, mentally oriented and getting informed consent. for the study.
Key exclusion criteria
Exclusion criteria: patients without informed consent, who is difficult to insert arterial pressure line, change of surgical procedure, re-do operation, emergency surgery, who is intubated, IABP insertion, Pacemaker insertion, and who cannot insert pulmonary aortic catheter.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misa Kajitani |
Organization
Kawasaki Saiwai Hospital
Division name
Department of anesthesiology
Zip code
Address
31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan
TEL
044-544-4611
misa@yj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misa Kajitani |
Organization
Kawasaki saiwai hospital
Division name
Department of anesthesiology
Zip code
Address
31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan
TEL
044-544-4611
Homepage URL
misa@yj8.so-net.ne.jp
Sponsor or person
Institute
Kawasaki saiwai hosipital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki saiwai hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 12 | Month | 18 | 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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034756
