UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046162 |
|---|---|
| Receipt number | R000052693 |
| Scientific Title | Finger cuff arterial pressure monitoring: Verification of ipsilaterality and contralaterality |
| Date of disclosure of the study information | 2021/11/24 |
| Last modified on | 2021/11/30 08:54:38 |
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Basic information
Public title
Finger cuff arterial pressure monitoring: Verification of ipsilaterality and contralaterality
Acronym
Finger cuff arterial pressure monitoring: Verification of ipsilaterality and contralaterality
Scientific Title
Finger cuff arterial pressure monitoring: Verification of ipsilaterality and contralaterality
Scientific Title:Acronym
Finger cuff arterial pressure monitoring: Verification of ipsilaterality and contralaterality
Region
| Japan |
Condition
Condition
Aortic arterial aneurysm
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose: The measurement accuracy of ClearSightTM (Edwards, USA), which enables continuous blood pressure measurement with noninvasive finger cuff, is being verified with reference to the invasive arterial pressure. However, many of the currently published literature cites the following two biases that cause measurement errors in arterial pressure and ClearSight blood pressure 1, 2. "Since it was measured in the ipsilateral upper limb, the insertion of the radial artery catheter affected the finger artery pressure" or "because it was measured in the contralateral upper limb, there may have been arteriosclerosis that caused a difference in blood pressure between the left and right upper limbs. Affects the measurement error. " This prospective observational study was planned for the purpose of further understanding the limitations of those study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement error of invasive arterial pressure and ClearSight arterial pressure during general anesthesia
Key secondary outcomes
Factors of measurement error
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
elective surgery
Key exclusion criteria
emergence surgery
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Yaguchi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
3170077
Address
jonanchou 2-1-1
TEL
0294231111
musasum0710@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
3170077
Address
jonanchou2-1-1
TEL
0294231111
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi general hospital
Address
Hitachi Jounanchou 2-1-1
Tel
0294231111
musasum0710@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Monitor both ClearSight blood pressure and invasive arterial pressure during surgery
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052693
