UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028163
Receipt number R000032234
Scientific Title Reliability of continuous noninvasive arterial pressure measuring instrument
Date of disclosure of the study information 2017/07/10
Last modified on 2021/07/13 15:13:40

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Basic information

Public title

Reliability of continuous noninvasive arterial pressure measuring instrument

Acronym

Reliability of continuous noninvasive arterial pressure measuring instrument

Scientific Title

Reliability of continuous noninvasive arterial pressure measuring instrument

Scientific Title:Acronym

Reliability of continuous noninvasive arterial pressure measuring instrument

Region

Japan


Condition

Condition

Pregnant women planning selective caesarean section

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For caesarean section with varied circulatory dynamics, compares the reliability of noninvasive arterial pressure measurement with invasive arterial pressure

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference in measured blood pressure between invasive and noninvasive arterial pressure(Measured up to 10 minutes after birth every minute)

Key secondary outcomes



Base

Study type

Observational


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

18 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

Pregnant women(ASA-PS1,2) scheduled for selective caesarean section

Key exclusion criteria

Atrial fibrillation, aortic regurgitation, severe pregnancy hypertension, allen test positive

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumihiro Matsuura

Organization

Self-Defence Forces Central Hospital

Division name

Anethesiology

Zip code


Address

1-2-24 Ikejiri Setagaya-ku, Tokyo

TEL

03-3411-0151

Email

fumihirog1012898@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumihiro Matsuura

Organization

Self-Defence Forces Central Hospital

Division name

Anesthesiology

Zip code


Address

1-2-24 Ikejiri Setagaya-ku, Tokyo

TEL

03-3411-0151

Homepage URL


Email

fumihirog1012898@yahoo.co.jp


Sponsor or person

Institute

Self-Defence Forces Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Self-Defence Forces Central Hospital

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

自衛隊中央病院


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 10 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

2017 Year 05 Month 01 Day

Date of IRB

2017 Year 07 Month 05 Day

Anticipated trial start date

2017 Year 07 Month 11 Day

Last follow-up date

2020 Year 09 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In selective caesarean section, invasive arterial pressure and noninvasive arterial pressure are measured and compared every 1 minute from before introduction of anesthesia to 10 minutes after delivery


Management information

Registered date

2017 Year 07 Month 10 Day

Last modified on

2021 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032234


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name