UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038112 |
|---|---|
| Receipt number | R000043446 |
| Scientific Title | An accutracy of core temperature monitoring system SpotOn in pediatric intensive care patients |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2019/09/26 16:44:13 |
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Basic information
Public title
An accutracy of core temperature monitoring system SpotOn in pediatric intensive care patients
Acronym
SpotOn in pediatric intensive care patients
Scientific Title
An accutracy of core temperature monitoring system SpotOn in pediatric intensive care patients
Scientific Title:Acronym
SpotOn in pediatric intensive care patients
Region
| Japan |
Condition
Condition
pediatric intensive care patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reliability of SpotOn in pediatric intensive care patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between core temperature measured with SpotOn and rectal temperature
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
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
critically ill pediatric patients requiring intensive care
Key exclusion criteria
patients with a heating device
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MASAFUMI |
| Middle name | |
| Last name | IDEI |
Organization
Tokyo Women's University Hospital
Division name
Department of Intensive Care Unit
Zip code
1628666
Address
31-1-1204
TEL
09055331052
masafumi203@yahoo.co.jp
Public contact
Name of contact person
| 1st name | MASAFUMI |
| Middle name | |
| Last name | IDEI |
Organization
Tokyo Women's University Hospital
Division name
Department of Intensive Care Unit
Zip code
1628666
Address
31-1-1204
TEL
09055331052
Homepage URL
masafumi203@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawa, Yokohama, Japan
Tel
09055331052
masafumi203@yahoo.co.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
| 2019 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retropspective study
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043446
