UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Errors in arterial/venous pressure levels measured using a non-invasive arterial/venous pressure measurement apparatus compared with conventional methods
Title of the study (Brief title)	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	Hiroshi Tomoeda
Organization	Chikugo City Hospital
Division name	Cardiovascularsurgery
Address	917-1 Izumi Chikugo Fukuoka Japan
TEL	090-7161-4276
Email	tomoeda.hiroshi@gmail.com

Public contact
Name of contact person	Hiroshi Tomoeda
Organization	Chikugo City Hospital
Division name	Cardiovascularsurgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 10 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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