UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014007 |
|---|---|
| Receipt number | R000016300 |
| Scientific Title | Non-invasive blood pressure monitoring using Doppler flow meter and ECG signals. |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2015/12/21 16:20:58 |
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Basic information
Public title
Non-invasive blood pressure monitoring using Doppler flow meter and ECG signals.
Acronym
Blood pressure monitoring with Doppler flow.
Scientific Title
Non-invasive blood pressure monitoring using Doppler flow meter and ECG signals.
Scientific Title:Acronym
Blood pressure monitoring with Doppler flow.
Region
| Japan |
Condition
Condition
Not specified
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of monitoring apparatus for blood pressure using ECG and Doppler flow signals
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acuity of blood pressure derived from the new apparatus.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Recording of ECG, blood pressure and Doppler flow signals.
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 under general anesthesia or staying in the ICU at the Kawasaki Medical Hospital.
Key exclusion criteria
Patients who did not agree to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Fujita |
Organization
Kawasaki Medical School
Division name
Anesthesiology & ICM 1
Zip code
Address
577 Matsushima Kurashiki-City Okayama 701-0192
TEL
086-462-1111
fujitay@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Fujita |
Organization
Kawasaki Medical School
Division name
Anesthesiology & ICM 1
Zip code
Address
577 Matsushima Kurashiki-City Okayama 701-0192
TEL
086-462-1111
Homepage URL
fujitay@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Anesthesiology & ICM 1
Institute
Department
Personal name
Funding Source
Organization
Japan Society of the Promotion of Sciences. Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.asaabstracts.com/
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 20 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016300
