UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Title of the study (Brief title)	Non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Region	Japan

Condition
Condition	Congenital heart desease
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Arterial catheterization (A-line) invasively monitors blood pressure when continuous measurement is required. However, as this method often causes pain or infection during or after arterial cannulation, it may prevent patients, particularly infants, from receiving emergency medical treatment. Therefore, we designed the present study to investigate the utility of non-invasive continuous blood pressure measurement using the painless plethysmogram method.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The Pearson's correlation coefficients were evaluated for the following two variables: rest-time blood pressure measured continuously by the plethysmogram method, and blood pressure continuously measured by the A-line method.
Key secondary outcomes

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	non-invasive continuous blood pressure measurement using plethysmogram method
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	0 years-old <=
Age-upper limit	16 years-old >
Gender	Male and Female
Key inclusion criteria	Infant patients at the Division of Cardiac Intensive Care Unit (CICU), who were undergoing general care using the A-line method.
Key exclusion criteria	Infant patients at CICU, who were undergoing general care not using the A-line method.
Target sample size	20

Research contact person
Name of lead principal investigator	Shingo Kasahara
Organization	Okayama University
Division name	Department of Gerontology Research
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7356
Email	shingok@md.okayama-u.ac.jp

Public contact
Name of contact person	Noriko Sakano
Organization	Okayama University
Division name	Department of Gerontology Research
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7356
Homepage URL
Email	snoriko@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	donation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 18 Day
Anticipated trial start date	2014 Year 03 Month 18 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	Published
URL releasing results
Results	The results demonstrate that the non-invasive plethysmogram method is highly correlated with the A-line method, with respect to continuous blood pressure measurement. Therefore, it can be used as a continuous blood pressure monitoring approach in clinical practice.
Other related information

Management information
Registered date	2015 Year 08 Month 17 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021556