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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046162
Receipt No. 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

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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
Email 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
Email musasum0710@yahoo.co.jp

Sponsor
Institute Hitachi general hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052693

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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