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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018700
Receipt No. R000021556
Scientific Title Utility of non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Date of disclosure of the study information 2015/08/20
Last modified on 2017/02/27

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Basic information
Public title Utility of non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Acronym Non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Scientific Title Utility of non-invasive continuous blood pressure measurement using plethysmogram method among infant patients with heart failure
Scientific Title:Acronym 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
1st name
Middle name
Last name Shingo Kasahara
Organization Okayama University
Division name Department of Gerontology Research
Zip code
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
1st name
Middle name
Last name Noriko Sakano
Organization Okayama University
Division name Department of Gerontology Research
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
2014 Year 03 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021556

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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