UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056644 |
|---|---|
| Receipt number | R000064743 |
| Scientific Title | Efficacy of High-Flow Nasal Cannula Oxygen Therapy in Rewarming: A Multicenter Study |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/12/01 19:55:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of High-Flow Nasal Cannula Oxygen Therapy in Rewarming: A Multicenter Study
Acronym
Efficacy of High-Flow Nasal Cannula Oxygen Therapy in Rewarming: A Multicenter Study
Scientific Title
Efficacy of High-Flow Nasal Cannula Oxygen Therapy in Rewarming: A Multicenter Study
Scientific Title:Acronym
Efficacy of High-Flow Nasal Cannula Oxygen Therapy in Rewarming: A Multicenter Study
Region
| Japan |
Condition
Condition
Accidental hypothermia patients
Classification by specialty
| Medicine in general | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of high-flow nasal cannula oxygen therapy (HFNC) in rewarming patients with accidental hypothermia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rewarming rate
Key secondary outcomes
Complication rate in emergency departments.
Complication rate after hospitalization.
28-day mortality.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of HFNC and usual rewarming
Interventions/Control_2
usual rewarming
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients aged 18 years or older who were transported by ambulance to the emergency division (ED) and diagnosed with accidental hypothermia
- Core body temperature below 33 degrees at the time of arrival on the ED.
Key exclusion criteria
- Implementation of mechanical ventilation.
- Implementation of blood warming (hemodialysis, etc.)
- Cases in which the time course of warming to 34 degrees is unknown.
- Cases in which abuse or harm from others are suspected.
- Non-consent to research.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Sakaguchi |
Organization
Yamagata university faculty of medicine
Division name
Emergency and critical care medicine
Zip code
990-9585
Address
iida-nishi, 2-2-2, yamagata city, Yamagata, Japan
TEL
023-628-5422
bealive32@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Sakaguchi |
Organization
Yamagata university faculty of medicine
Division name
Emergency and critical care medicine
Zip code
990-9585
Address
iida-nishi, 2-2-2, yamagata city, Yamagata, Japan
TEL
023-628-5422
Homepage URL
bealive32@yahoo.co.jp
Sponsor or person
Institute
Yamagata university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Yamagata university faculty of medicine
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
the Ethical Review Committee of Yamagata University Faculty of Medicine
Address
iida-nishi, 2-2-2, yamagata city, Yamagata, Japan
Tel
023-628-5047
yu-ikekenkyu@jm.kj.yamagata-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
| 2025 | Year | 01 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064743
