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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013232
Receipt No. 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

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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 Obsterics 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
Email 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
Email ane075@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015378

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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