UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037468 |
|---|---|
| Receipt number | R000042711 |
| Scientific Title | Accuracy of continuous non-invasive arterial pressure in infants and toddlers |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2025/07/28 19:44:41 |
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Basic information
Public title
Accuracy of continuous non-invasive arterial pressure in infants and toddlers
Acronym
Accuracy of continuous non-invasive arterial pressure in infants and toddlers
Scientific Title
Accuracy of continuous non-invasive arterial pressure in infants and toddlers
Scientific Title:Acronym
Accuracy of continuous non-invasive arterial pressure in infants and toddlers
Region
| Japan |
Condition
Condition
Patients < 36 months
Classification by specialty
| Surgery in general | Pediatrics | Anesthesiology |
| Laboratory medicine | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the accuracy of measurements with Clearsight in infants and toddlers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare continuous non-invasive arterial pressure measurement with Clearsight to invasive or non-invasive arterial pressure measurement.
Key secondary outcomes
Compare cardiac output and stroke volume with Clearsight to echocardiographic measurements.
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
| 3 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- A patient < 36 months
- Surgery requiring invasive arterial pressure measurement(catheter insertion to artery)
- A patient who has obtained informed consent from a parent
Key exclusion criteria
- Patient > 36 months
- Surgery with only by non-invasive arterial pressure measurement
- A patient who has not obtained explanatory consent
- Patients with extreme contraction in arteries (such as Raynaud's disease)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kimitoshi |
| Middle name | |
| Last name | Nishiwaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku
TEL
052-744-2340
nishi@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
466-8560
Address
65 Tsurumai-cho, Showa-ku
TEL
052-744-2340
Homepage URL
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
40
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku
Tel
052-744-2973
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
| 2020 | Year | 01 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
- intragroup comparison
Management information
Registered date
| 2019 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042711
