UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021761 |
|---|---|
| Receipt number | R000025097 |
| Scientific Title | Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM). |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2016/04/03 22:54:05 |
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Basic information
Public title
Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Acronym
Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Scientific Title
Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Scientific Title:Acronym
Relative clinical heat transfer effectiveness: Forced-air warming(Warm Touch TM) vs. Conductive fabric electric warming(HOT DOG TM).
Region
| Japan |
Condition
Condition
perioperative hypothermia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparative clinical heat transfer effectiveness when CFW and FAW are used as systems
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The warming rates of Tympanic temperatures were recorded at 15 minute intervals, starting when the blankets were energized.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Forced-air warming(Warm Touch TM)
Interventions/Control_2
Conductive fabric electric warming(HOT DOG TM)
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
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients(ASA PS 1-2) undergoing GI or gynecologic surgical procedures lasting more than 2 hours
Key exclusion criteria
Exclusion criteria were: ASA 3 and 4, BMI (kg/m2) <17 and >30, and the use of fluid warming
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo medical university school of medicine
Division name
Anesthesiology
Zip code
Address
West16South1,Sapporocity
TEL
011-688-9663
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruko Sugai |
Organization
Sapporo medical university school of medicine
Division name
Anesthesiology
Zip code
Address
West16South1,Sapporocity
TEL
011-688-9663
Homepage URL
hayashi.haruko@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
the Red Cross Hospital (Asahikawa, Japan)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 04 | 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
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
Main results already published
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 03 | Day |
Last modified on
| 2016 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025097
