UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038706 |
|---|---|
| Receipt number | R000044128 |
| Scientific Title | the efficacy of ten minutes pre-warming to body temperature |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2024/01/26 11:32:01 |
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Basic information
Public title
the efficacy of ten minutes pre-warming to body temperature
Acronym
the efficacy of ten minutes pre-warming to body temperature
Scientific Title
the efficacy of ten minutes pre-warming to body temperature
Scientific Title:Acronym
the efficacy of ten minutes pre-warming to body temperature
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether 10 minutes pre-warming has efficacy to reduce body temperature loss under general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body temperature loss 1 hour after general anesthesia induction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ten minutes pre-warming by hot air blanket
Interventions/Control_2
no pre-warming
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
general anesthesia
Key exclusion criteria
patient's reject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Tanaka |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
770-8503
Address
50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture
TEL
0886313111
Kawanishi.riyosuke@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kawanishi |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
770-8503
Address
50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture
TEL
0886313111
Homepage URL
Kawanishi.riyosuke@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University
Address
50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture
Tel
0886313111
Kawanishi.riyosuke@tokushima-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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
http://medical.med.tokushima-u.ac.jp/jmi/vol70/pdf/70-1,2p74.pdf
Publication of results
Published
Result
URL related to results and publications
http://medical.med.tokushima-u.ac.jp/jmi/vol70/pdf/70-1,2p74.pdf
Number of participants that the trial has enrolled
40
Results
A normal body temperature maintenance effect was observed in the 10-minute prewarming.
Results date posted
| 2023 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Adult women undergoing breast surgery with written informed consent
Participant flow
Randomly assigned to prewarming and control groups.
After entering the operating room, the prewarming group was warmed for 10 minutes by a forced air warming system.
The control group was kept warm with blankets.
Both groups underwent the usual induction of general anesthesia, and body temperature was measured every 15 minutes for 90 minutes.
Adverse events
none
Outcome measures
Body Temperature Trends
Normal body temperature maintenance time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044128
