UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057467 |
|---|---|
| Receipt number | R000065645 |
| Scientific Title | The accuracy of non-invasive central venous pressure measurement in pediatric patients. |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/05/27 22:41:25 |
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Basic information
Public title
The accuracy of non-invasive central venous pressure measurement in pediatric patients.
Acronym
The accuracy of non-invasive central venous pressure measurement in pediatric patients.
Scientific Title
The accuracy of non-invasive central venous pressure measurement in pediatric patients.
Scientific Title:Acronym
The accuracy of non-invasive central venous pressure measurement in pediatric patients.
Region
| Japan |
Condition
Condition
Pediatric patients in intensive care units
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of non-invasive estimated central venous pressure (CVP) using an upper arm cuff compared with conventional CVP measured using a central venous catheter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy between non-invasive estimated central venous pressure (CVP) using an upper arm cuff and conventional CVP measured using a central venous catheter.
Key secondary outcomes
Tracking ability between non-invasive estimated central venous pressure (CVP) using an upper arm cuff and conventional CVP measured using a central venous catheter.
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients admitted to the surgical intensive care unit at our institution
Cases in which a central venous catheter was placed for intensive care
Pediatric patients aged 0 to 15 years
Key exclusion criteria
Written consent from a guardian (aged 18 or over) cannot be obtained
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442340
plus9@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Fujii |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIHON KOHDEN CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Clinical Research Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
0527442479
ethics@med.nagoya-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
| 2025 | Year | 07 | Month | 01 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065645
