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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017051
Receipt No. R000019732
Scientific Title Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Date of disclosure of the study information 2015/04/06
Last modified on 2016/03/28

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Basic information
Public title Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Acronym Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Scientific Title Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Scientific Title:Acronym Utility of the "A-namaran", a device to fix the arterial catheter: a Prospective, Ramdomized, Controlled Clinical Trial
Region
Japan

Condition
Condition Patients who undergo surgery under general anesthesia at Niigata University Medical and Dental Hospital. In adition, they plan to need radial arterial catheterization and we will be able to access to the catheter insertion site during operation.
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 An arterial catheter often becomes bent, leading to overamping of pressure waveform and occlusion of a catheter. If the catheter is fixed using a film dressings as described in package insert (conventional method) , the catheter is likely to be bent at the insertion site due to its compresssion.
We previously reported that we developed the new fixation method (pillow method) and showed that it keeps a catheter patent better than conventional method (J clin Anesth 2012 ; 36 : 1457-62). Based on this study, we developed the device which we named 'A-namaran'.
The purpose of this study is to see whether the fixation using 'A-namaran' keeps a catheter patent better than the conventional method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The need for an intervention to improve catheter bent.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Fix the arterial catheter using A-namaran.
Interventions/Control_2 Fix the arterial catheter by conventional method.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo surgery under general anesthesia at Niigata University Medical and Dental Hospital. In adition, they plan to need radial arterial catheterization and we will be able to access to the catheter insertion site during operation.
Key exclusion criteria ASA PS <= 4
>20 years old or <=80 years old
Peripheral vascular disease such as vasculitis
Cannot obtain participant's or his relative's consent
An artery other than radial artery is catherterized
Any other case that the principal investigator or a member of the study judged to be excluded
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuro Kohno
Organization Niigata University Medical and Dental Hospital
Division name Department of Anesthesiology
Zip code
Address 754 Asahimachidoori_ichibanchou, Chuuouku, Niigatashi, Niigata, 951-8520, Japan
TEL 0025-223-6161
Email Kohno-t@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Hashimoto
Organization Niigata University Medical and Dental Hospital
Division name Department of Anesthesiology
Zip code
Address 754 Asahimachidoori_ichibanchou, Chuuouku, Niigatashi, Niigata, 951-8520, Japan
TEL 0025-223-6161
Homepage URL
Email Thashimoto-nii@umin.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor SUNARROW LIMITED
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 06 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
The incidence of corrective interventions in Group A was significantly lower than that in Group C (4.1% vs. 18.8%, P < 0.05).
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
2015 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 18 Day
Last follow-up date
2015 Year 12 Month 14 Day
Date of closure to data entry
2015 Year 12 Month 14 Day
Date trial data considered complete
2015 Year 12 Month 14 Day
Date analysis concluded
2015 Year 12 Month 14 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 06 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019732

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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