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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024448
Receipt No. R000028135
Scientific Title Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Date of disclosure of the study information 2016/10/27
Last modified on 2017/10/19

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Basic information
Public title Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Acronym Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Scientific Title Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Scientific Title:Acronym Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Region
Japan

Condition
Condition Descending aortic aneurysm, Thoracoabdominal aortic aneurysm
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Paraplegia is a serious potential complication of descending aortic replacement(DAR) and thoracoabdominal aortic replacement(TAAR). DHCA has been applied in DAR and TAAR due to low risk of paraplegia. Normally MEP disappear in DHCA, but MEP have been used to confirm whether motor function is intact after DHCA. It's crucial to know the timing and the body temperature at MEP recovery in the rewarming phase. Therefore we will investigate the recovery time and the body temperature of MEP reappearance.
Basic objectives2 Others
Basic objectives -Others We will examine which factors have an association with the recovery time of MEP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recovery time of MEP
Key secondary outcomes the body temperature at MEP recovery

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent DAR and TAAR with DHCA between January 2013 and December 2015
Key exclusion criteria Lack of MEP data,
Non lower extremity circulatory arrest,
Intraoperative death
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Yoshitani
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesiology
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL 06-6833-5012
Email sohtamikaze@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Eiki Kanemaru
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesiology
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email eiki-k.16@hotmail.co.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We extracted the data, recover time of MEP, the bladder and nasopharyngeal temperature when MEP recovered, the lower extremity circulatory arrest time, the rewarming time, and the lowest hemoglobin concentration.

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2017 Year 10 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028135

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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