UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059740 |
|---|---|
| Receipt number | R000067997 |
| Scientific Title | Observational Study Evaluating the Accuracy of Moni-Patch, a Wireless Core Temperature Monitoring Device, in Critically Ill Patients in the Intensive Care Unit |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/11 13:44:32 |
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Basic information
Public title
Observational Study on the Moni-Patch, a Wireless Thermometer, in Critically Ill Patients in the Intensive Care Unit
Acronym
Observational Study on the Moni-Patch Thermometer in the Intensive Care Unit
Scientific Title
Observational Study Evaluating the Accuracy of Moni-Patch, a Wireless Core Temperature Monitoring Device, in Critically Ill Patients in the Intensive Care Unit
Scientific Title:Acronym
Observational Study Evaluating the Accuracy of the Moni-Patch Thermometer in the Intensive Care Unit
Region
| Japan |
Condition
Condition
Critically ill patients admitted to the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy and reliability of the Moni-Patch, a wireless thermometer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement and correlation between core temperature measured by the Moni-Patch thermometer and blood 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult critically ill patients admitted to the intensive care unit of Yokohama City University Hospital during the study period
Key exclusion criteria
Patients who did not provide consent to participate in the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Idei |
Organization
Yokohama City University Hospital
Division name
Department of Intensive Care Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
0457872800
masafumi203@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Idei |
Organization
Yokohama City University Hospital
Division name
Department of Intensive Care Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
0457872800
Homepage URL
masafumi203@gmail.com
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
Research Ethics Committee of Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
0457872800
rinri@yokohama-cu.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 | 11 | Month | 11 | 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
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067997
