Unique ID issued by UMIN | UMIN000038795 |
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Receipt number | R000043880 |
Scientific Title | The effectiveness of cooling headgear on intraoperative core temperature management during pediatric complex congenital heart surgery |
Date of disclosure of the study information | 2019/12/06 |
Last modified on | 2021/09/20 16:08:52 |
The effectiveness of cooling headgear on intraoperative core temperature management during pediatric complex congenital heart surgery
The effectiveness of cooling headgear on intraoperative core temperature management
The effectiveness of cooling headgear on intraoperative core temperature management during pediatric complex congenital heart surgery
The effectiveness of cooling headgear on intraoperative core temperature management
Japan |
Congenital complex heart disease
Pediatrics | Anesthesiology | Cardiovascular surgery |
Others
NO
Whether cooling head gear is effective on the core temperature management or not
Efficacy
Confirmatory
Pragmatic
Not applicable
core temperature
the difference between core and peripheral temperature
peripheral temperature
heart rate
regional saturation of brain
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Device,equipment |
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.
The commercially available cooling pack were placed on the head of the controlled patients between the end of cardiopulmonary bypass and operation.
1 | months-old | <= |
72 | months-old | >= |
Male and Female
elective bi-ventricular repair
the duration between the end of cardiopulmonary bypass and operation, which is less than 30 minutes, and unexpectable bleeding were excluded.
20
1st name | Wataru |
Middle name | |
Last name | Sakai |
Hokkaido Medical Center for Child Health and Rehabilitation
Anesthesiology
006-0041
6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041 Japan
0116915696
sakaiwataru1128@gmail.com
1st name | Wataru |
Middle name | |
Last name | Sakai |
Hokkaido Medical Center for Child Health and Rehabilitation
Anesthesiology
006-0041
6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041, Japan
0116915696
sakaiwataru1128@gmail.com
Hokkaido Medical Center for Child Health and Rehabilitation
No
Other
No
No
Hokkaido Medical Center for Child Health and Rehabilitation
6, 240, 1 chome, 1 jyo, Kanayama, Teine, Sapporo, Hokkaido, 006-0041, Japan
0116915696
sakaiwataru1128@gmail.com
NO
北海道子ども総合医療・療育センター
2019 | Year | 12 | Month | 06 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 12 | Month | 06 | Day |
2019 | Year | 08 | Month | 29 | Day |
2019 | Year | 12 | Month | 06 | Day |
2023 | Year | 12 | Month | 06 | Day |
2023 | Year | 12 | Month | 06 | Day |
2023 | Year | 12 | Month | 06 | Day |
2023 | Year | 12 | Month | 06 | Day |
No. 211
2019 | Year | 12 | Month | 05 | Day |
2021 | Year | 09 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043880
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