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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025121
Receipt No. R000028885
Scientific Title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (randomized controlled trial).
Date of disclosure of the study information 2016/12/04
Last modified on 2018/12/04

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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 (randomized controlled trial).
Acronym An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (randomized controlled trial).
Scientific Title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (randomized controlled trial).
Scientific Title:Acronym An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (randomized controlled trial).
Region
Japan

Condition
Condition none
Classification by specialty
Anesthesiology
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, conventional 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 randomized controlled trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Procedural success, which is defined as successful guide-wire insertion without the occurrence of posterior wall puncture.
Key secondary outcomes The duration of the procedure.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Performing ultrasound-guided internal jugular vein puncture using combined short-axis and long-axis approach (intervention).
Interventions/Control_2 Performing ultrasound-guided internal jugular vein puncture using long-axis approach(control).
Interventions/Control_3 Performing ultrasound-guided internal jugular vein puncture using short-axis approach (control).
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 120

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 075-593-4111
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 075-641-9161
Homepage URL
Email t-k-s-t@koto.kpu-m.ac.jp

Sponsor
Institute Rakuwakai Otowa Hospital
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
2016 Year 12 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2016 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 04 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
2016 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028885

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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