UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024715 |
|---|---|
| Receipt number | R000028302 |
| Scientific Title | Errors in arterial/venous pressure levels measured using a non-invasive arterial/venous pressure measurement apparatus compared with conventional methods |
| Date of disclosure of the study information | 2016/11/05 |
| Last modified on | 2017/12/20 21:22:23 |
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Basic information
Public title
Errors in arterial/venous pressure levels measured using a non-invasive arterial/venous pressure measurement apparatus compared with conventional methods
Acronym
Non-invasive Arterial/Venous Pressure Measurement Apparatus
Scientific Title
Errors in arterial/venous pressure levels measured using a non-invasive arterial/venous pressure measurement apparatus compared with conventional methods
Scientific Title:Acronym
Non-invasive Arterial/Venous Pressure Measurement Apparatus
Region
| Japan |
Condition
Condition
Varicose veins, healthy individuals, patients with high blood pressure, intensive care patients
Classification by specialty
| Cardiology | Surgery in general | Dermatology |
| Plastic surgery | Aesthetic surgery | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are already reports of non-invasive venous pressure measuring methods using ultrasonic diagnostic equipment, but errors have been reported when measuring venous pressure over 50 mmHg. We have created a non-invasive apparatus that measures pressure in veins and arteries of 200 mmHg or lower, in 15 seconds. This is a significantly shorter time than with conventional methods. We aimed to prove that there is no difference between non-invasive arterial or venous measurements obtained using this device and conventional pricking or cuff methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proof that there is no error in the measurements obtained using the non-invasive arterial/venous pressure device we have developed compared with conventional methods.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Consenting patients for whom measuring central vein pressure was necessary for treatment, for which a central vein line was already inserted.
2. Consenting healthy individuals whose upper or lower extremity vein pressure was normal, patients with high blood pressure, and patients with varicose veins in a lower extremity.
Key exclusion criteria
Healthy individuals or patients, who can not keep standing on their tiptoes.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tomoeda |
Organization
Chikugo City Hospital
Division name
Cardiovascularsurgery
Zip code
Address
917-1 Izumi Chikugo Fukuoka Japan
TEL
090-7161-4276
tomoeda.hiroshi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tomoeda |
Organization
Chikugo City Hospital
Division name
Cardiovascularsurgery
Zip code
Address
917-1 Izumi Chikugo Fukuoka Japan
TEL
090-7161-4276
Homepage URL
tomoeda.hiroshi@gmail.com
Sponsor or person
Institute
Chikugo City Hospital
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
| 2016 | Year | 11 | Month | 05 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 11 | Month | 04 | Day |
Last modified on
| 2017 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028302
