UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019858 |
|---|---|
| Receipt number | R000022021 |
| Scientific Title | Thermal effect of air warmer blanket on donor of living liver transplantation |
| Date of disclosure of the study information | 2015/11/22 |
| Last modified on | 2016/01/06 14:35:20 |
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Basic information
Public title
Thermal effect of air warmer blanket on donor of living liver transplantation
Acronym
Thermal effect of air warmer blanket on donor of living liver transplantation
Scientific Title
Thermal effect of air warmer blanket on donor of living liver transplantation
Scientific Title:Acronym
Thermal effect of air warmer blanket on donor of living liver transplantation
Region
| Japan |
Condition
Condition
Donor of living liver transplantation
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the difference of thermal effect between air warmer blankets on donor of living liver transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of thermal effect between upper-type air warmer blanket and under-type blanket.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
We warm patients by upper body type blanlet(3M Bair Hugger Temperature Management Blanket Upper Body Model 52200), and we measure distal esophageal temparature as core tenparature (cetral temparature).
Intervention period is during patient is in the operation room.
Interventions/Control_2
We warm patients by under body type blanlet(3M Bair Hugger Temperature Management Blanket Lithotomy Underbody Model 58501), and we measure distal esophageal temparature as core tenparature (cetral temparature).
Intervention period is during patient is in the operation room.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who is 20 years and older.
Patient who can understand the the research program fully.
Patient who can assume and agree.
Key exclusion criteria
Patient who underwent emergency surgery.
Consent has been revoked.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Hoka |
Organization
Kyushu University
Division name
Department of anesthesiology and critical care medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-5714
shoka@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Hayamizu |
Organization
Kyushu University hospital
Division name
Department of surgery
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka, Japan
TEL
092-642-5714
Homepage URL
hayamizu.kengo.906@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Department of anesthesiology and critical care 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
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | 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
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022021
