UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017051
Receipt number 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 20:04:03

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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 or person

Institute

Niigata University Medical and Dental Hospital

Institute

Department

Personal name



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

Value
https://center6.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