UMIN-CTR Clinical Trial

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 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
Email	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
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	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, JAPAN
Tel	0227178006
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032059