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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036536
Receipt No. R000041625
Scientific Title Retrospective observational study of a new temperature continuous monitoring system under hypothermic cardiopulmonary bypass
Date of disclosure of the study information 2019/04/17
Last modified on 2019/04/17

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Basic information
Public title Retrospective observational study of a new temperature continuous monitoring system under hypothermic cardiopulmonary bypass
Acronym Retrospective observational study of a new temperature continuous monitoring system under hypothermic cardiopulmonary bypass
Scientific Title Retrospective observational study of a new temperature continuous monitoring system under hypothermic cardiopulmonary bypass
Scientific Title:Acronym Retrospective observational study of a new temperature continuous monitoring system under hypothermic cardiopulmonary bypass
Region
Japan

Condition
Condition Cardiovascular surgery with cardiopulmonary bypass
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the temperature estimated by TEMPLE TOUCH PROTM and nasopharyngeal temperature under hypothermic cardiopulmonary bypass.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bland-Altman analysis for temperature estimated by TEMPLE TOUCH PROTM and nasopharyngeal temperature
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients performed for elective cardiovascular surgery under cardiopulmonary bypass
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akari
Middle name
Last name Yoshida
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code 641-0012
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL 073-441-0611
Email akari@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Akari
Middle name
Last name Yoshida
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code 641-0012
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL 073-441-0611
Homepage URL
Email akari@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Department of Anesthesiology
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
Tel 0734472300
Email wa-rinri@wakayama-med.ac.jp

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 04 Month 17 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 9
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
2019 Year 02 Month 06 Day
Date of IRB
2019 Year 02 Month 06 Day
Anticipated trial start date
2019 Year 02 Month 06 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Temperature was measured by using TEMPLE TOUCH PROTM and nasopharyngeal probe under hypothermic cardiopulmonary bypass.

Management information
Registered date
2019 Year 04 Month 17 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041625

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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