UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022909 |
|---|---|
| Receipt number | R000026400 |
| Scientific Title | Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2016/06/27 15:06:34 |
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Basic information
Public title
Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Acronym
Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Scientific Title
Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Scientific Title:Acronym
Effects of Forced-Air Warming by an Underbody-Type Blanket: a Propensity Score-Matched Analysis
Region
| Japan |
Condition
Condition
Intraoperative hypothermia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the effect of forced-air warming by the underbody-type blanket on anesthetized patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Body temperature at the start and end of surgery in the anesthetized patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Underbody-type blanket for forced-air warming
Interventions/Control_2
Conventional blanket for forced-air 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
All patients who underwent surgery between April 2014 and November 2015
Key exclusion criteria
None
Target sample size
8032
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
shigekazu.sugino.d3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
Homepage URL
shigekazu.sugino.d3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine,
Department of Anesthesiology and Perioperative Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 18 | 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
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026400
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
