UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015636
Receipt number R000018172
Scientific Title The optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging
Date of disclosure of the study information 2014/11/08
Last modified on 2018/02/06 14:40:23

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Basic information

Public title

The optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging

Acronym

The insertion depth of the peripherally inserted central venous catheter using the ultrasound

Scientific Title

The optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging

Scientific Title:Acronym

The insertion depth of the peripherally inserted central venous catheter using the ultrasound

Region

Japan


Condition

Condition

Patiens who is required to place the central venous catheter.

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to predict the optimal insertion depth of the peripherally inserted central venous catheter using the ultrasound imaging and external landmarks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The distance between a catheter tip and the carina by chest X-ray.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

period: October 27, 2014 to March 31, 2016.
We confirm the catheter tip in the subclavian vein using ultrasound image, then the external distance between catheter tip and the second right costal cartilage to the manubriosternal joint was measured. The catheter was inserted and secured to the depth determined ultrasound and external landmarks.

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

Patiens who is required to place the central venous catheter.

Key exclusion criteria

Inflammation, infection, mass at the puncture site.

the catheter insertion site except for the arm is preferred.

the catheter insertion on the arm is difficult.

Patients who is determined inadequate by the administrator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouhei Iwashita

Organization

Faculty of medicine, Fukuoka University

Division name

Anesthesiology

Zip code


Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka

TEL

092-801-1011

Email

iwashita@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kouhei Iwashita

Organization

Faculty of medicine, Fukuoka University

Division name

Anesthesiology

Zip code


Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka

TEL

092-801-1011

Homepage URL


Email

iwashita@fukuoka-u.ac.jp


Sponsor or person

Institute

Faculty of Medicine, Fukuoka University

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

2014 Year 11 Month 08 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

No longer recruiting

Date of protocol fixation

2014 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 08 Day

Last follow-up date

2015 Year 03 Month 17 Day

Date of closure to data entry

2015 Year 03 Month 17 Day

Date trial data considered complete

2015 Year 03 Month 17 Day

Date analysis concluded

2018 Year 02 Month 06 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 08 Day

Last modified on

2018 Year 02 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name