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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024715
Receipt No. 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

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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
Email 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
Email tomoeda.hiroshi@gmail.com

Sponsor
Institute Chikugo City Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028302

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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