UMIN-CTR Clinical Trial

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
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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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
Email	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
Email	nobukofu@luke.ac.jp

Sponsor
Institute	St.Luke's International University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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Other related organizations
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IRB Contact (For public release)
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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
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Results
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Results Delayed
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Baseline Characteristics
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036105

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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