UMIN-CTR Clinical Trial

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