UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021570
Receipt number R000023364
Scientific Title Noninvasive measurement of hemodynamic status by oscillometric method
Date of disclosure of the study information 2016/04/01
Last modified on 2018/12/26 17:14:22

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Basic information

Public title

Noninvasive measurement of hemodynamic status by oscillometric method

Acronym

Noninvasive measurement of hemodynamic status by oscillometric method

Scientific Title

Noninvasive measurement of hemodynamic status by oscillometric method

Scientific Title:Acronym

Noninvasive measurement of hemodynamic status by oscillometric method

Region

Japan


Condition

Condition

Adult elective surgery patient(over 20 years old)

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The validation for conventional way of the new measurement method of pulse pressure variation(PPV) and central venous pressure(CVP)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The estimation of error between estimated PPV and measured PPV.
The estimation of error between estimated CVP and measured CVP.

Key secondary outcomes

Safety of our method.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Duration: During the stay in operating room.
Frequency: 12 times or more at 10 minutes or more intervals.
Head down or head up of operating table. (Each maneuver performed once)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are planned measuring arterial pressure by arterial catheter or are planned measuring central venous pressure.
Patients who are informed enough and presents the will of participation to this study by written form.

Key exclusion criteria

Patients who are unsuitable for attaching the pressure cuff at both upper arms by reason of surgical procedure or physical impairment.
Patients who withdraw his informed consent.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Kawamoto

Organization

Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Anesthesiology and Critical Care

Zip code


Address

1-2-3,Kasumi,Minami-ku,Hiroshima

TEL

81-082-256-3234

Email

anekawa@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryuji Nakamura

Organization

Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

Division name

Department of Anesthesiology and Critical Care

Zip code


Address

1-2-3,Kasumi,Minami-ku,Hiroshima

TEL

81-082-256-3234

Homepage URL


Email

r-nacamura@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

広島大学病院(広島県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 01 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

Completed

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 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

2016 Year 03 Month 22 Day

Last modified on

2018 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023364


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name