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

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 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


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

Value
https://center6.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