UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016290
Receipt number R000018899
Scientific Title An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension
Date of disclosure of the study information 2015/01/22
Last modified on 2018/03/24 23:48:59

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Basic information

Public title

An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension

Acronym

A comparative study of inflationary NIBP and deflationary NIBP in measuring clinical hypotension

Scientific Title

An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension

Scientific Title:Acronym

A comparative study of inflationary NIBP and deflationary NIBP in measuring clinical hypotension

Region

Japan


Condition

Condition

Cardiovascular surgery which used cardiopulmonary bypass

Classification by specialty

Anesthesiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine whether an inflationary NIBP can quickly measure blood pressure below 80 mmHg compared with a conventional deflationary NIBP.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time required to measure blood pressure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Intervention group: NIBP is measured with an inflationary method.
Duration of intervention: during general anesthesia

Interventions/Control_2

Control group: NIBP is measured with a conventional deflationary method.

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

The patients who scheduled for elective cardiovascular surgery under cardiopulmonary bypass

Key exclusion criteria

1.Patients with obvious vascular lesion in upper or lower extremities
2.Patients who have a hemodialysis shunt
3.Patients who have bilateral difference in NIBP of upper extremities

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akari Yoshida

Organization

Wakayama Medical University

Division name

Department of Anesthesiology

Zip code


Address

811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan

TEL

073-441-0611

Email

akari.firefly@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Akari Yoshida

Organization

Wakayama Medical University

Division name

Department of Anesthesiology

Zip code


Address

811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan

TEL

073-441-0611

Homepage URL


Email

akari.firefly@gmail.com


Sponsor or person

Institute

Wakayama Medical University
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

NIHON KOHDEN CORPORATION

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

和歌山県立医科大学附属病院(和歌山県)


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 22 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

Terminated

Date of protocol fixation

2015 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 01 Month 21 Day

Last modified on

2018 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name