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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037468
Receipt No. 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 2019/10/08

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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
Email 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
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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
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
2019 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2022 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
2019 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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