UMIN-CTR Clinical Trial

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

Condition
Condition	Congenital complex heart disease
Classification by specialty	Pediatrics Anesthesiology Cardiovascular surgery
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 the end of cardiopulmonary and the end of 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 between the end of cardiopulmonary bypass and operation.
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 months-old <=
Age-upper limit	72 months-old >=
Gender	Male and Female
Key inclusion criteria	elective bi-ventricular repair
Key exclusion criteria	the duration between the end of cardiopulmonary bypass and operation, which is less than 30 minutes, and unexpectable bleeding were excluded.
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	北海道子ども総合医療・療育センター

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	2021 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043880