UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062863 |
|---|---|
| Receipt number | R000071958 |
| Scientific Title | Efficacy and safety of plastic bag use for the prevention of accidental hypothermia during cold-water immersion |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 18:29:30 |
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Basic information
Public title
Effects of waterproofing on body temperature during cold-water immersion
Acronym
Cold-Water Immersion Study
Scientific Title
Efficacy and safety of plastic bag use for the prevention of accidental hypothermia during cold-water immersion
Scientific Title:Acronym
Cold-Water Immersion Hypothermia Prevention Study
Region
| Japan |
Condition
Condition
Accidental hypothermia
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of preventing direct water contact using a plastic bag on core temperature and metabolic responses during cold-water immersion, and to assess its potential utility and safety for the prevention of accidental hypothermia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in core temperature (Tc) over time during cold-water immersion and the post-immersion recovery period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants undergo 60 min of cold-water immersion while wearing clothing and enclosed in a commercially available plastic bag to prevent direct contact between the body and water.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 20 to <70 years who provided written informed consent to participate in the study.
Key exclusion criteria
No specific exclusion criteria were predefined.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Oshiro |
Organization
Sapporo Kojinkai Memorial Hospital
Division name
Cardiovascular Department
Zip code
063-0052
Address
Miyanosawa2-1-16-1, Nishi-ku,Sapporo city
TEL
011-665-0020
sangakui.jp@gmail.com
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Oshiro |
Organization
Sapporo Kojinkai Memorial Hospital
Division name
Cardiovascular Department
Zip code
063-0052
Address
Miyanosawa2-1-16-1, Nishi-ku,Sapporo city
TEL
011-665-0020
Homepage URL
sangakui.jp@gmail.com
Sponsor or person
Institute
Kazue Oshiro
Cardiovascular Department
Sapporo Kojinkai Memorial Hospital
Institute
Department
Personal name
Kazue Oshiro
Funding Source
Organization
Sapporo Kojinkai Memorial Hospital
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
Sapporo Kojinkai Memorial Hospital
Address
Miyanosawa2-1-16-1, Nishi-ku, Sapporo city
Tel
011-665-0020
sangakui.jp@gmail.com
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
| 2026 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Protocol is not publicly available.
Publication of results
Unpublished
Result
URL related to results and publications
Results are not publicly available elsewhere.
Number of participants that the trial has enrolled
6
Results
Results is delayed
Results date posted
| 2026 | Year | 09 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The study has been completed, and a manuscript reporting the study results is currently being prepared for submission to a peer-reviewed journal. As the results have not yet been published, posting of the study results is delayed.
Date of the first journal publication of results
Baseline Characteristics
Results is delayed
Participant flow
Results is delayed
Adverse events
None
Outcome measures
Results is delayed
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071958
