UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052944 |
|---|---|
| Receipt number | R000060408 |
| Scientific Title | Investigation of the difference in central venous pressure values between the distal and proximal lumens of a central venous catheter |
| Date of disclosure of the study information | 2023/11/29 |
| Last modified on | 2023/11/29 12:35:11 |
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Basic information
Public title
Investigation of the difference in central venous pressure values between the distal and proximal lumens of a central venous catheter
Acronym
Investigation of the difference in central venous pressure values between the distal and proximal lumens of a central venous catheter
Scientific Title
Investigation of the difference in central venous pressure values between the distal and proximal lumens of a central venous catheter
Scientific Title:Acronym
Investigation of the difference in central venous pressure values between the distal and proximal lumens of a central venous catheter
Region
| Japan |
Condition
Condition
pediatric patients undergoing open heart surgery for congenital heart disease
Classification by specialty
| Vascular surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The connection to the proximal or distal lumen of the central venous catheter (CVC) varies from facility to facility. Whether the central venous pressure (CVP) measurement line is connected to the proximal lumen of the central venous catheter (CVC) or to the distal lumen depends on the institution. This study will investigate whether it is preferable to connect the CVP measurement line to the CVC distal lumen or whether connecting the CVP measurement line to the CVC proximal lumen provides sufficiently reliable CVP values by comparing whether there is a difference between CVP values measured at the CVC proximal lumen and the proximal lumen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is to ascertain whether there is a difference in CVP values measured at the CVC proximal lumen and the proximal lumen.
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
pediatric patient undergoing open heart surgery for congenital heart disease
Key exclusion criteria
cases without cardiopulmonary bypass
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
yamatomo@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
Homepage URL
yamatomo@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tomohiro Yamamoto
Funding Source
Organization
Niigata University
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
Ethics Committee at Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
Tel
+81-25-227-2625
ethics@adm.niigata-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060408
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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