UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038706
Receipt number R000044128
Scientific Title the efficacy of ten minutes pre-warming to body temperature
Date of disclosure of the study information 2020/02/01
Last modified on 2024/01/26 11:32:01

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Basic information

Public title

the efficacy of ten minutes pre-warming to body temperature

Acronym

the efficacy of ten minutes pre-warming to body temperature

Scientific Title

the efficacy of ten minutes pre-warming to body temperature

Scientific Title:Acronym

the efficacy of ten minutes pre-warming to body temperature

Region

Japan


Condition

Condition

general anesthesia

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess whether 10 minutes pre-warming has efficacy to reduce body temperature loss under general anesthesia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body temperature loss 1 hour after general anesthesia induction

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ten minutes pre-warming by hot air blanket

Interventions/Control_2

no pre-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

20 years-old <=

Age-upper limit

86 years-old >

Gender

Male and Female

Key inclusion criteria

general anesthesia

Key exclusion criteria

patient's reject

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Katsuya
Middle name
Last name Tanaka

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

770-8503

Address

50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture

TEL

0886313111

Email

Kawanishi.riyosuke@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Kawanishi

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

770-8503

Address

50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture

TEL

0886313111

Homepage URL


Email

Kawanishi.riyosuke@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokushima University

Address

50-1, 2 Cho-me, Kuramoto Cho, Tokushima City, Tokushima prefecture

Tel

0886313111

Email

Kawanishi.riyosuke@tokushima-u.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

2020 Year 02 Month 01 Day


Related information

URL releasing protocol

http://medical.med.tokushima-u.ac.jp/jmi/vol70/pdf/70-1,2p74.pdf

Publication of results

Published


Result

URL related to results and publications

http://medical.med.tokushima-u.ac.jp/jmi/vol70/pdf/70-1,2p74.pdf

Number of participants that the trial has enrolled

40

Results

A normal body temperature maintenance effect was observed in the 10-minute prewarming.

Results date posted

2023 Year 05 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Adult women undergoing breast surgery with written informed consent

Participant flow

Randomly assigned to prewarming and control groups.
After entering the operating room, the prewarming group was warmed for 10 minutes by a forced air warming system.
The control group was kept warm with blankets.
Both groups underwent the usual induction of general anesthesia, and body temperature was measured every 15 minutes for 90 minutes.

Adverse events

none

Outcome measures

Body Temperature Trends
Normal body temperature maintenance time

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 11 Month 27 Day

Date of IRB

2020 Year 01 Month 20 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2020 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 11 Month 27 Day

Last modified on

2024 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name