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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016881
Receipt No. R000019597
Scientific Title Prewarming prevents perioperative hypothermia
Date of disclosure of the study information 2015/04/01
Last modified on 2016/08/15

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Basic information
Public title Prewarming prevents perioperative hypothermia
Acronym Prewarming prevents perioperative hypothermia
Scientific Title Prewarming prevents perioperative hypothermia
Scientific Title:Acronym Prewarming prevents perioperative hypothermia
Region
Japan

Condition
Condition Patients undergoing general anesthesia for elective surgery
Classification by specialty
Urology Anesthesiology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of thirty minutes prewarming on intraoperative hypothermia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Reduce decreases of body temperature in an hour at induction of general anesthesia
Key secondary outcomes Prevent a hypothermia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 thirty minutes prewarming with BairPaws
Interventions/Control_2 Wear BairPaws, but no 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Elective Urology surgery on general anesthesia, supine or lithotomy position
Key exclusion criteria Physical status of American society of anesthesiologist class 3 and over
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Fukushima
Organization National Hospital Organization Mito Medical Center
Division name Anesthesiology
Zip code
Address Ibarakiken higashiibarakigun ibarakimachi sakuranosato 280
TEL 029-240-7711
Email hisashi28@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Fukushima
Organization National Hospital Organization Mito Medical Center
Division name Anesthesiology
Zip code
Address Ibarakiken higashiibarakigun ibarakimachi sakuranosato 280
TEL 029-240-7711
Homepage URL
Email hisashi28@aol.com

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
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
2015 Year 04 Month 01 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 Completed
Date of protocol fixation
2014 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 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 03 Month 23 Day
Last modified on
2016 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019597

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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