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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030441
Receipt No. R000034756
Scientific Title Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Date of disclosure of the study information 2017/12/18
Last modified on 2019/05/26

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Basic information
Public title Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Acronym Non-invasive continuous cardiac monitoring comparison
Scientific Title Comparison of non-invasive continuous cardiac monitoring for thoracic aortic aneurysm surgery
Scientific Title:Acronym Non-invasive continuous cardiac monitoring comparison
Region
Japan

Condition
Condition Thoracic aortic aneurysm
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of non-invasive cardiac output monitoring during thoracic aortic aneurysm surgery and post-cardiac surgery state in ICU
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation the accuracy and trending ability of CCO, APCO, esCCO
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 Inclusion criteria is patients undergoing elective thoracic aortic aneurysm surgery performing PAC and APCO monitoring, age>20years old, mentally oriented and getting informed consent. for the study.
Key exclusion criteria Exclusion criteria: patients without informed consent, who is difficult to insert arterial pressure line, change of surgical procedure, re-do operation, emergency surgery, who is intubated, IABP insertion, Pacemaker insertion, and who cannot insert pulmonary aortic catheter.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Misa Kajitani
Organization Kawasaki Saiwai Hospital
Division name Department of anesthesiology
Zip code
Address 31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan
TEL 044-544-4611
Email misa@yj8.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misa Kajitani
Organization Kawasaki saiwai hospital
Division name Department of anesthesiology
Zip code
Address 31-27 Omiyacho, Saiwai-ku, Kawasaki, Kanagawa, Japan
TEL 044-544-4611
Homepage URL
Email misa@yj8.so-net.ne.jp

Sponsor
Institute Kawasaki saiwai hosipital
Institute
Department

Funding Source
Organization Kawasaki saiwai hospital
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
2017 Year 12 Month 18 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 Completed
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
2017 Year 04 Month 27 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 12 Month 18 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034756

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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