UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026165
Receipt number R000030065
Scientific Title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).
Date of disclosure of the study information 2017/02/16
Last modified on 2019/02/18 12:11:59

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Basic information

Public title

An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).

Acronym

An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).

Scientific Title

An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).

Scientific Title:Acronym

An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (prospective observational trial).

Region

Japan


Condition

Condition

none

Classification by specialty

Anesthesiology Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We perform internal jugular vein puncture using a novel ultrasound-guided puncture technique which combines short-axis approach and long-axis approach or conventional short-axis approach. We compare two approaches about the successful insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture without penetrating the posterior wall in the prospective observational trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Procedural success, which is defined as successful guide-wire insertion without the occurrence of posterior wall puncture and with the needle tip visualized at the time of the anterior wall puncture.

Key secondary outcomes

The duration of the procedure.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients who go through operations under general anesthesia in Rakuwakai Otowa Hospital, and need for insertion of central venous catheter or pulmonary artery catheter for perioperative management.

Key exclusion criteria

Emergency operation. Patients who do not agree with this study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Fukumoto

Organization

Rakuwakai Otowa Hospital

Division name

Department of Cardiothoracic surgery

Zip code


Address

2 Otowach, Chinji-cho, Yamashina-ku, Kyoto, Japan

TEL

81-75-593-4111

Email

fukumotoatsushi@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Jun Takeshita

Organization

National Hospital Organization Kyoto Medical Center

Division name

Department of Emergency and Critical Care Medicine

Zip code


Address

1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan

TEL

81-75-641-9161

Homepage URL


Email

t-k-s-t@koto.kpu-m.ac.jp


Sponsor or person

Institute

Rakuwakai Otowa Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2017 Year 02 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.jcvaonline.com/article/S1053-0770(18)30610-4/fulltext

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

Main results already published

Date of protocol fixation

2015 Year 04 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 14 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information

prospective observational cohort study


Management information

Registered date

2017 Year 02 Month 16 Day

Last modified on

2019 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030065


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name