UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An open labeled randomized comparative study of newly developed inflationary non-invasive blood pressure monitor (NIBP) and conventional deflationary NIBP in measuring clinical hypotension
Title of the study (Brief title)	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	Akari Yoshida
Organization	Wakayama Medical University
Division name	Department of Anesthesiology
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	Akari Yoshida
Organization	Wakayama Medical University
Division name	Department of Anesthesiology
Address	811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL	073-441-0611
Homepage URL
Email	akari.firefly@gmail.com

Sponsor
Institute	Wakayama Medical University Department of Anesthesiology
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018899