UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051254 |
|---|---|
| Receipt number | R000058449 |
| Scientific Title | Estimation of hemodynamic status (blood pressure, pulse rate) and prediction of hemodynamic changes from pulse wave using wearable terminal in patients requiring systemic management in HCU. |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/03 16:31:44 |
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Basic information
Public title
Monitoring hemodynamic status (blood pressure, pulse) and predicting dynamic changes using wearable devices in patients requiring systemic management while in the HCU
Acronym
Hemodynamic monitoring and prediction study of dynamic changes using wearable devices in intensive care
Scientific Title
Estimation of hemodynamic status (blood pressure, pulse rate) and prediction of hemodynamic changes from pulse wave using wearable terminal in patients requiring systemic management in HCU.
Scientific Title:Acronym
Hemodynamic (blood pressure, pulse rate) estimation from pulse wave and prediction of hemodynamic changes in intensive care
Region
| Japan |
Condition
Condition
Heart failure (circulatory failure), hypotension, shock
Classification by specialty
| Medicine in general | Cardiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand hemodynamics (blood pressure and pulse rate) and predict dynamic changes in critically ill patients with circulatory failure based on estimated pulse rate and blood pressure from pulse wave using a wearable device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Assessing the accuracy of immediate measurement of vital signs from arterial catheters versus estimated vital signs
Differences between future predicted dynamics and actual dynamic fluctuations
Key secondary outcomes
Correlation with oxygen saturation, body temperature, and other related measures of cardiovascular indices
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who meet the criteria for admission to the intensive care unit and who have given consent to the study description.
Patients with an indwelling arterial catheter.
Key exclusion criteria
Patients who did not consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Saitama Medical University
Division name
General international medicine
Zip code
350
Address
38 Monohongo, Monoyama-Cho, Iruma-gun, Saitama, JPN
TEL
0492761667
kobatake@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takehito |
| Middle name | |
| Last name | KOBAYASHI |
Organization
Saitama Medical University
Division name
General Internal Medicine
Zip code
350-0495
Address
38 Monohongo, Monoyama-Cho, Iruma-gun, Saitama, JPN
TEL
0492761667
Homepage URL
kobatake@saitama-med.ac.jp
Sponsor or person
Institute
saitama medical university
Institute
Department
Personal name
Takehito KOBAYASHI
Funding Source
Organization
Grants-in-Aid for Scientific Research(KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Saitama Medical University General Research Fund
IRB Contact (For public release)
Organization
Saitama Medical University Hospital Institutional Review Board
Address
38, Muro Hongo, Muroyama-cho, Iruma-gun, Saitama, Japan
Tel
0492761354
hirb@saitama-med.ac.jp
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
埼玉医科大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Improvements will be made to previous devices.
Preparing to apply for a patent on the research results.
Management information
Registered date
| 2023 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
