UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036557
Receipt number R000041654
Scientific Title Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in surgical patients with prone position
Date of disclosure of the study information 2019/04/20
Last modified on 2019/10/22 20:22:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in surgical patients with prone position

Acronym

Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in surgical patients with prone position

Scientific Title

Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in surgical patients with prone position

Scientific Title:Acronym

Comparison of the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis in surgical patients with prone position

Region

Japan


Condition

Condition

Patients undergoing surgery in prone position

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the non-invasive blood pressure with the invasive blood pressure using the Error Grid analysis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Non-invasive pressure and invasive blood pressure measured during general anesthesia

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing surgery in prone position

Key exclusion criteria

Atrial fibrillation
Patients without invasive arterial line

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Email

suehirokoichi@yahoo.co.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan

TEL

06-6645-2186

Homepage URL


Email

suehirokoichi@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology
Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology
Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Osaka City University Graduate School of Medicine

Address

1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan

Tel

81-6-6646-6125

Email

ethics@med.osaka-cu.ac.jp


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

2019 Year 04 Month 20 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

100

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

No longer recruiting

Date of protocol fixation

2019 Year 02 Month 14 Day

Date of IRB

2019 Year 03 Month 22 Day

Anticipated trial start date

2019 Year 04 Month 20 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Simultaneous measurement of non-invasive blood pressure and invasive blood pressure will be performed. Error Grid analysis will be conducted to compare the non-invasive blood pressure with the invasive blood pressure.


Management information

Registered date

2019 Year 04 Month 20 Day

Last modified on

2019 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name