UMIN-CTR Clinical Trial

Public title

An investigation of the clinical effectiveness of fixing the probe to the skin during ultrasound-guided central venous cannulation.

Acronym

An investigation of the clinical effectiveness of fixing the probe to the skin during ultrasound-guided central venous cannulation.

Scientific Title

An investigation of the clinical effectiveness of fixing the probe to the skin during ultrasound-guided central venous cannulation.

Scientific Title:Acronym

An investigation of the clinical effectiveness of fixing the probe to the skin during ultrasound-guided central venous cannulation.

Region

Japan

Condition

Patients undergoing central venous cannulation

Classification by specialty

Anesthesiology	Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Central venous cannulation is not always safe even with using ultrasound guidance, which may be due to two factors, operator and patient. To show an appropriate image of needle and vein depends on operator skill. Since a needle stretches the venous wall as it approaches, the tip of needle can penetrate the anterior and posterior venous wall simultaneously, which may lead to injuries of artery and nerve. In this research, we are going to investigate whether fixing the ultrasound probe to the skin with a double-sided adhesive tape would produce stable image, and whether dilating the vein with the fixed probe would cause safer cannulation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

The extent of venous dilation

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Cannulation to the internal jugular vein. Pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_2

Cannulation to the internal jugular vein. Not pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_3

Cannulation to the femoral vein. Pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_4

Cannulation to the femoral vein. Not pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_5

Cannulation to the axillary vein. Pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_6

Cannulation to the axillary vein. Not pulling straight upward the probe stuck to the skin by using a sterile double-sided adhesive tape. It will be finished after finishing the cannulation.

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing central venous cannulation

Key exclusion criteria

Patients whose respiration and hemodynamics will be expected to be impaired under each study condition

Target sample size

280

Name of lead principal investigator

1st name
Middle name
Last name	Hitoshi YOSHIDA

Organization

Hirosaki University Graduate School of Medicine

Division name

Emergncy and Disaster Medicine

Zip code

Address

5 Zaifu-cho, Hirosaki, Aomori

TEL

0172-33-5111

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hirosaki University Graduate School of Medicine

Division name

Emergncy and Disaster Medicine

Zip code

Address

5 Zaifu-cho, Hirosaki, Aomori

TEL

0172-33-5111

Homepage URL

Email

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

31

Day

Last modified on

2015

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010840