UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027991 |
|---|---|
| Receipt number | R000032059 |
| Scientific Title | Usefulness of underbody-type blanket for forced-air warming in surgical patients under general anesthesia |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2022/07/04 21:45:39 |
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Basic information
Public title
Usefulness of underbody-type blanket for forced-air warming in surgical patients under general anesthesia
Acronym
Usefulness of underbody-type blanket
Scientific Title
Usefulness of underbody-type blanket for forced-air warming in surgical patients under general anesthesia
Scientific Title:Acronym
Usefulness of underbody-type blanket
Region
| Japan |
Condition
Condition
Surgical patients under general anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Forced-air warming is useful for prevention of intraoperative hypothermia. Our previous study suggested that underbody-type blanket was superior to upperbody-type one (UMIN000024853). The aim of this study is to compare these two types of blankets in prospective study design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature at the end of surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Forced-air warming by underbody-type blanket during surgery
Interventions/Control_2
Forced-air warming by overbody-type blanket during surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elective open abdominal surgery, lithtomy position, and 1 or 2 of ASA Physical Status
Key exclusion criteria
Heart failure, resipiratory failure, liver cirrohsis, more than 2mg/dL of creatine, pregnacy, CNS disease, psychiatry disease, less than 18 of body masss index, more than 35 of body mass index, less tha 7g/dL of hemoglobin, less than 2 g/dL of albumin, and massive ascites
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-0874
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177321
shigekazu.sugino.d3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-0874
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL
0227177321
Homepage URL
shigekazu.sugino.d3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University,Department of Anesthesiology and Perioperative Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University,Department of Anesthesiology and Perioperative Medicine
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
Tel
0227178006
med-kenkyo@grp.tohoku.ac.jp
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
| 2017 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Publication of results
Partially published
Result
URL related to results and publications
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Number of participants that the trial has enrolled
51
Results
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Results date posted
| 2022 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 10 | Month | 21 | Day |
Baseline Characteristics
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Participant flow
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Adverse events
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Outcome measures
http://www.asaabstracts.com/strands/asaabstracts/abstract.htm?year=2019&index=8&absnum=1116
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032059
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| Registered date | File name |
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