UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038795
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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043880


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name