UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022952 |
|---|---|
| Receipt number | R000026430 |
| Scientific Title | Comparison of cerebral oximetry dynamics during thoracic aortic aneurysm repair, using transcranial near-infrared spectroscopy |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2021/07/05 15:57:49 |
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Basic information
Public title
Comparison of cerebral oximetry dynamics during thoracic aortic aneurysm repair, using transcranial near-infrared spectroscopy
Acronym
Cerebral oximeter comparison during Aortic arch replacement
Scientific Title
Comparison of cerebral oximetry dynamics during thoracic aortic aneurysm repair, using transcranial near-infrared spectroscopy
Scientific Title:Acronym
Cerebral oximeter comparison during Aortic arch replacement
Region
| Japan |
Condition
Condition
Aortic arch anuerysm
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accuracy evaluation of cerebral oximetry measurement with NIRO-200X and INVOS-4100 during aortic aneurysm repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of cerebral oximetry monitoring with NIRO-200X and INVOS-4100 during cardiopulmonary bypass under nonpulsatile blood flow
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients undergoing aortic arch replacement repair
Key exclusion criteria
change of surgical procedure, patients who have central nervous system disorder and who can not take consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Kajitani |
Organization
Kawasaki saiwai hospital
Division name
Department of anesthesiology
Zip code
212-0014
Address
31-27 Omiya-tyou Saiwai-ku, Kawasaki. Kanagawa
TEL
044-544-4611
misa@yj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Misa |
| Middle name | |
| Last name | Kajitani |
Organization
Kawasaki saiwai hospital
Division name
Department of anesthesiology
Zip code
212-0014
Address
31-27 Omiya-tyou Saiwai-ku, Kawasaki. Kanagawa
TEL
044-544-4611
Homepage URL
misa@yj8.so-net.ne.jp
Sponsor or person
Institute
Kawasaki saiwai hospital
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
Kawasaki Saiwai Hospital
Address
Oomiyacho, Saiwai-ku, Kawasaki-shi, Kanagawa, Japan
Tel
044-544-4611
misa@yj8.so-net.ne.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2016 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026430
