UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018700 |
|---|---|
| Receipt number | 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 18:53:20 |
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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
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
snoriko@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021556
