UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Noninvasive measurement of hemodynamic status by oscillometric method
Title of the study (Brief title)	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	Masashi Kawamoto
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
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	Ryuji Nakamura
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
Address	1-2-3,Kasumi,Minami-ku,Hiroshima
TEL	81-082-256-3234
Homepage URL
Email	r-nacamura@hiroshima-u.ac.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023364