UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031638 |
|---|---|
| Receipt number | R000036105 |
| Scientific Title | Correlation between Central Venous Pressure and the Short, Long Diameter and Area from Cross-Sectional Images of the Inferior Vena Cava measured with Three-dimensional Transesophageal Echocardiography in Anesthetized Mechanically Ventilated Patients |
| Date of disclosure of the study information | 2018/03/09 |
| Last modified on | 2018/04/10 13:13:51 |
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Basic information
Public title
Correlation between Central Venous Pressure and the Short, Long Diameter and Area from Cross-Sectional Images of the Inferior Vena Cava measured with Three-dimensional Transesophageal Echocardiography in Anesthetized Mechanically Ventilated Patients
Acronym
Correlation between the Inferior Vena Cava diameter and Central Venous Pressure using Three-dimensional Transesophageal Echocardiography in Mechanically Ventilated Patients
Scientific Title
Correlation between Central Venous Pressure and the Short, Long Diameter and Area from Cross-Sectional Images of the Inferior Vena Cava measured with Three-dimensional Transesophageal Echocardiography in Anesthetized Mechanically Ventilated Patients
Scientific Title:Acronym
Correlation between the Inferior Vena Cava diameter and Central Venous Pressure using Three-dimensional Transesophageal Echocardiography in Mechanically Ventilated Patients
Region
| Japan |
Condition
Condition
Patients having cardiac surgery under general anesthesia
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between central venous pressure and short diameter, long diameter and area of cross-sectional images of the inferior vena cava using three-dimensional transesophageal echocardiography in anesthesiatized mechanically ventilated patients
Basic objectives2
Others
Basic objectives -Others
To investigate the correlation between dimeter of the inferior vena cava and preoperative cardiac function, postoperative complications, length of stay of intensive care unit and hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between short diameter, long diameter and area of the inferior vena cava from cross-sectional images and central venous pressure during cardiac operation
Key secondary outcomes
preoperative cardiac function, postoperative complications, length of stay of intensive care unit and hospital.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients having cardiac surgery under general anesthesia
Key exclusion criteria
1)Patients with contraindications to TEE
2) Patients who refused to participate the study
3)Patients under 20 years old and over 90 years old
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuko Fujita |
Organization
St.Luke's International hospital
Division name
Department of Anesthesia
Zip code
Address
9-1 Akashi-cho Chuo-ku, Tokyo, 104-8560, Japan
TEL
81-3-3541-5151
nobukofu@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuko Fujita |
Organization
St.Luke's International hospital
Division name
Department of Anesthesia
Zip code
Address
9-1 Akashi-cho Chuo-ku, Tokyo, 104-8560, Japan
TEL
81-3-3541-5151
Homepage URL
nobukofu@luke.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
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
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
| 2018 | Year | 03 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
For cardiac surgery, central venous catheter and TEE are indispensable monitors and routinely inserted. After induction of general anesthesia, CVP and IVC dimeters and area will be measured by using 3D-TEE. It is also measured after closure of sternum.
Management information
Registered date
| 2018 | Year | 03 | Month | 08 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036105
