UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038796 |
|---|---|
| Receipt number | 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 | 2021/09/20 16:14:17 |
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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 peripheral and 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
peripheral temperature during operation
Key secondary outcomes
the difference between core and peripheral temperature
core 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
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
sakaiwataru1128@gmail.com
Sponsor or person
Institute
Hokkaido Medical Center for Child Health and Rehabilitation
Institute
Department
Personal name
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
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
| 2021 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043954
