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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009237
Receipt No. R000010840
Scientific Title An investigation of the clinical effectiveness of fixing the probe to the skin during ultrasound-guided central venous cannulation.
Date of disclosure of the study information 2012/11/01
Last modified on 2015/03/25

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Basic information
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
Condition Patients undergoing central venous cannulation
Classification by specialty
Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes The extent of venous dilation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Last 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

Public contact
1st 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

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 11 Month 01 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
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
Other related information

Management information
Registered date
2012 Year 10 Month 31 Day
Last modified on
2015 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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