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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038796
Receipt No. R000043954
Scientific Title The effectiveness of cooling headgear on intraoperative core temperature management during pediatric heart palliative surgery
Date of disclosure of the study information 2019/12/06
Last modified on 2020/05/26

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Basic information
Public title The effectiveness of cooling headgear on intraoperative core temperature management during pediatric heart palliative surgery
Acronym The effectiveness of cooling headgear on intraoperative core temperature management
Scientific Title The effectiveness of cooling headgear on intraoperative core temperature management during pediatric heart palliative surgery
Scientific Title:Acronym The effectiveness of cooling headgear on intraoperative core temperature management
Region
Japan

Condition
Condition Pediatric congenital heart disease
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Whether cooling head gear is effective on the core temperature management or not
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes core temperature
Key secondary outcomes the difference between core and peripheral temperature
peripheral temperature
heart rate
regional saturation of brain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Cooling head gear (Gentherm Medical 600 MAXI-THERM LITE HEADWRAP; Cincinnati Sub-Zero Products, LLC, USA) is used during surgery with 5 to 40 Celsius-degrees. The target core temperature is 37.0 Celsius-degrees.
Interventions/Control_2 The commercially available cooling pack were placed on the head of the controlled patients 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
1 days-old <=
Age-upper limit
1095 days-old >
Gender Male and Female
Key inclusion criteria Blalock-Taussig/ central shunt or Pulmonary Artery banding
Key exclusion criteria no
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Wataru
Middle name
Last name Sakai
Organization Hokkaido Medical Center for Child Health and Rehabilitation
Division name Anesthesiology
Zip code 006-0041
Address 6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041 Japan
TEL 0116915696
Email sakaiwataru1128@gmail.com

Public contact
Name of contact person
1st name Wataru
Middle name
Last name Sakai
Organization Hokkaido Medical Center for Child Health and Rehabilitation
Division name Anesthesiology
Zip code 006-0041
Address 6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041, Japan
TEL 0116915696
Homepage URL
Email sakaiwataru1128@gmail.com

Sponsor
Institute Hokkaido Medical Center for Child Health and Rehabilitation
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor No
Name of secondary funder(s) No

IRB Contact (For public release)
Organization Hokkaido Medical Center for Child Health and Rehabilitation
Address 6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041, Japan
Tel 0116915696
Email sakaiwataru1128@gmail.com

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
2019 Year 12 Month 06 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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 06 Day
Date of IRB
2019 Year 08 Month 29 Day
Anticipated trial start date
2019 Year 12 Month 06 Day
Last follow-up date
2023 Year 12 Month 06 Day
Date of closure to data entry
2023 Year 12 Month 06 Day
Date trial data considered complete
2023 Year 12 Month 06 Day
Date analysis concluded
2023 Year 12 Month 06 Day

Other
Other related information No. 211

Management information
Registered date
2019 Year 12 Month 05 Day
Last modified on
2020 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043954

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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