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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027991
Receipt No. 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 2017/11/10

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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
Obsterics 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
Middle name
Last name Shigekazu Sugino
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL 0227177321
Email shigekazu.sugino.d3@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigekazu Sugino
Organization Tohoku University
Division name Department of Anesthesiology and Perioperative Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
TEL 0227177321
Homepage URL
Email shigekazu.sugino.d3@tohoku.ac.jp

Sponsor
Institute Tohoku University,Department of Anesthesiology and Perioperative Medicine
Institute
Department

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
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
2017 Year 06 Month 30 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 06 Month 29 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032059

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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