UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026484 |
|---|---|
| Receipt number | R000030421 |
| Scientific Title | Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease |
| Date of disclosure of the study information | 2017/03/10 |
| Last modified on | 2026/03/17 08:01:17 |
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Basic information
Public title
Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Acronym
ezCVP
Scientific Title
Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Scientific Title:Acronym
Feasibility of enclosed zone oscillatory technique for the estimation of central venous pressure in patients with cardiovascular disease
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility of novel non-invasive technique designated as ezCVP to estimate the central venous pressure in patient with heart failure and other cardiovascular diseases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between estimated CVP measured by non-invasive technique and CVP measured by invasive technique
Key secondary outcomes
Safety of CVP measured by non-invasive technique
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of ezCVP is performed at the end of right heart catheterization.
The investigator wraps the blood pressure cuff around patient`s upper arm and starts the measurement of cuff pressure by using automated sphygmomanometer equipped with the algorithm suitable for venous pressure measurement.
The cuff pressure is kept at 50 mm Hg for 30 seconds to measure the respiratory change of venous pressure.
Then, cuff pressure is gradually reduced by 5 mm Hg every 6 seconds from 50 mm Hg to 5 mm Hg.
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
Patient over 20 years old when informed consent is obtained.
Patients who are planned for right heart catheterization because of clinical reason.
Patient who can provide written informed consent
Key exclusion criteria
Patient who can not put cuffs on both side upper arm by scheduled procedures or physical reasons.
Patient who judged inappropriate for conducting the study by the researcher or research sharing person
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name
Department of Cardiovascular Regeneration and Medicine
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5555
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hidaka |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Division name
Department of cardiovascular medicine
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5540
Homepage URL
hida-taka@umin.ac.jp
Sponsor or person
Institute
Research Institute for Radiation Biology and Medicine, Hiroshima University
Department of Cardiovascular Regeneration and Medicine
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for integrated medical research
Address
1-2-3 kasumi, minamiku, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-u.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000030421
Publication of results
Partially published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000030421
Number of participants that the trial has enrolled
97
Results
ezCVP was significantly correlated with CVP . ezCVP had an underestimation bias of -2.5 mm Hg with 95% limits of agreement of -14.1 mmHg and 9.6 mm Hg for CVP . The AUCof ROC with ezCVP to detect the CVP >=12 cm H2O and CVP >10 mm Hg were 0.81 or 0.88, respectively. The sensitivity, specificity and positive likelihood ratio of ezCVP for the CVP >=8.8 mm Hg and CVP > 10 mm Hg were 0.59, 0.96 and 14.8 with a cut-off value of 11.9 and 0.79, 0.97 and 26.3 with a cut-off value of 12.7.
Results date posted
| 2019 | Year | 09 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 25 | Day |
Baseline Characteristics
patients with coronary artery disease (n=9), valvular heart disease (n=54), cardiomyopathy (n=30) and other diseases (n=4).
Participant flow
We included 97 patients who were older than 20 years of age and underwent right-heart catheterization at Hiroshima University Hospital from April 2017 to December 2017.
Adverse events
none
Outcome measures
the feasibility of ezCVP measurement and the relationship between ezCVP and CVP measured by a catheter.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030421
