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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048559
Receipt No. R000055327
Scientific Title Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room
Date of disclosure of the study information 2022/08/05
Last modified on 2022/08/03

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Basic information
Public title Effects of pre-post warming in the operating room and clarification and unification of clinical judgments on temperature management
Acronym Effects of pre-post warming in the operating room and clarification and unification of clinical judgments on temperature management
Scientific Title Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room
Scientific Title:Acronym Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room
Region
Japan

Condition
Condition Laparoscopic gastrectomy or enterectomy
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will compare the temperature management protocol including pre-post warming and conventional temperature management, and clarify the effect on perioperative temperature management.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body temperature from the time of entering the operating room to the time of leaving the room
Key secondary outcomes presence or absence of shivering
heart rate
average blood pressure
amount of blood loss
presence or absence of pressure ulcers
presence of hot or cold

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Forced-air warming with an underbody blanket before and after surgery
Interventions/Control_2 Forced-air warming with an overbody blanket before and after 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

Not applicable
Gender Male and Female
Key inclusion criteria 1.over 20 years old
2.American Society of Anesthesiologists physical status 1 or 2
3.Persons whose consent has been obtained by signing a consent form by the patient or a surrogate
Key exclusion criteria 1.robot-assisted surgery
2.emergency surgery
3.Patients with known or suspected malignant hyperthermia
4.American Society of Anesthesiologists physical status 3 or higher
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Wakisaka
Organization Hamamatsu University School of Medicine
Division name Clinical Nursing, Adult Nursing
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, Japan
TEL 0534352828
Email wakisaka@hama-med.ac.jp

Public contact
Name of contact person
1st name Hirona
Middle name
Last name Ishihara
Organization Seirei Mikatahara General Hospital
Division name nursing department
Zip code 433-8558
Address 3453 Mikatahara-cho, Kita-ku, Hamamatsu City, Shizuoka, Japan
TEL 0534361251
Homepage URL
Email M20015@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Seirei Mikatahara General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, Japan
Tel 0534352680
Email rinri@hama-med.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 聖隷三方原病院(静岡県)

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 05 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 Preinitiation
Date of protocol fixation
2022 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2022 Year 09 Month 01 Day
Last follow-up date
2023 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 03 Day
Last modified on
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055327

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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