UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016881 |
|---|---|
| Receipt number | R000019597 |
| Scientific Title | Prewarming prevents perioperative hypothermia |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2016/08/15 08:14:47 |
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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
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
hisashi28@aol.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019597
