UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013232 |
|---|---|
| Receipt number | R000015378 |
| Scientific Title | Intraoperative effect of heat retaining device for extrimities |
| Date of disclosure of the study information | 2014/02/24 |
| Last modified on | 2014/02/24 08:50:45 |
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Basic information
Public title
Intraoperative effect of heat retaining device for extrimities
Acronym
Intraoperative effect of heat retaining device for extrimities
Scientific Title
Intraoperative effect of heat retaining device for extrimities
Scientific Title:Acronym
Intraoperative effect of heat retaining device for extrimities
Region
| Japan |
Condition
Condition
Adults (20 years old or older) undergoing surgery in gynecologic neoplastic disease, lung tumor
Classification by specialty
| Chest surgery | Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Reduction of post-operative complications and improvement of satisfaction with prevention of hypothermia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Satisfaction of anesthesia and presence of shivering
Key secondary outcomes
Peripheral and core body temperature during surgery,arterial blood oxygen saturation and perfusion index value
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Use heat insulation equipment for limbs durling operation
Interventions/Control_2
Use hot air warming device durling operation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults who does not have serious complications undergoing surgery for gynecological neoplastic disease, lung tumor(ASA PS 1 and 2)
Key exclusion criteria
Patient with eczema on extrimities
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka MedicalCollege
Division name
Dept. of Anesthesiology
Zip code
Address
2-7 Daigakumachi Takatsukishi Osaka Pref. Japan
TEL
072-683-1221
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiro Ohchi |
Organization
Osaka Medikal College
Division name
Dept of Anesthesiology
Zip code
Address
2-7 Daigakumachi Takatsukishi Osaka Pref. Japan
TEL
072-683-1221
Homepage URL
ane075@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
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
| 2014 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 24 | 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
| 2014 | Year | 02 | Month | 24 | Day |
Last modified on
| 2014 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015378
