UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013420
Receipt number R000015403
Scientific Title Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.
Date of disclosure of the study information 2014/03/15
Last modified on 2017/01/24 23:47:48

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Basic information

Public title

Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.

Acronym

Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.

Scientific Title

Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.

Scientific Title:Acronym

Examination about BD NexivaTM closed IV Catheter System of use in peripheral intravenous or intra-arterial cannulation.

Region

Japan


Condition

Condition

The patients aged 20-85 years old, who were ASA-PS 1-3.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We studied the efficacy and safety of BD Nexiva TM for intravenous and intra-arterial cannulation, by comparing clinically BD Nexiva TM and a conventional catheter needle( Surshield Surflo II).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcomes were the number of blood exposures for cannulation, and the number of attempts at insertion of the cannula.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are 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

BD Nexiva TM .

Interventions/Control_2

Surshield Surflo II.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who were scheduled for elective surgery ,and who were ASA-PS 1-3.

Key exclusion criteria

Patients who were diagnosed arteriosclerotic disease ( coronary artery disease, cerebrovascular disease, arteriosclerosis obliterans, etc.).

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuki Maruyama

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2670

Email

y5maruyama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Tanaka

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code


Address

3-1-1 Asahi, Matsumoto, Nagano

TEL

0263-37-2670

Homepage URL


Email

s_tanaka@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Resuscitology, University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nippon Becton Dickinson Company, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 15 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

Terminated

Date of protocol fixation

2014 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 03 Month 14 Day

Last modified on

2017 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015403


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name