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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014011
Receipt No. R000016195
Scientific Title Optimal central venous catheter insertion depth using the pericardial reflection as a landmark.
Date of disclosure of the study information 2014/05/20
Last modified on 2014/05/20

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Basic information
Public title Optimal central venous catheter insertion depth using the pericardial reflection as a landmark.
Acronym Optimal central venous catheter insertion depth using the pericardial reflection as a landmark.
Scientific Title Optimal central venous catheter insertion depth using the pericardial reflection as a landmark.
Scientific Title:Acronym Optimal central venous catheter insertion depth using the pericardial reflection as a landmark.
Region
Japan

Condition
Condition central venous catheter insertion
Classification by specialty
Medicine in general Surgery in general Anesthesiology
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine safe and optimal methods for determining central venous catheter insertion depth.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the ratio of a central venous catheter tip above the pericardial reflection.
Key secondary outcomes The distance of the carina and a tip of central venous catheter on the immediate post operative anterior-posterior chest X-ray.

Adverse events related to central venous catheter insertion.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 S group:skin surface landmark group.
A CVC insertion depth is decided by the formula below.
(the straight length between the needle insertion point and the upper edge of right clavicular notch)+(the length between the upper edge of right clavicular notch and the upper edge of second right costal cartilage to the manubriosternal joint.)
Interventions/Control_2 T group: chest X-ray group.
A CVC insertion depth is decided by the formula below.
(the straight length between the needle insertion point and the upper edge of right clavicular notch)+(the vertical distance between the upper edge of right clavicular notch and the carina measured on the preoperative posterior-anterior CRX using the picture archiving and communication system in each hospital.)
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 elective cardiovascular sugery cases.
Key exclusion criteria Patients with vascular malformation in great vessels.
Reoperation case.
Age under 20 years old,
Patients with ICD or pacemaker.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gaku Inagawa
Organization Yokohama Municipal hospital
Division name Department of anesthesiology
Zip code
Address 56 Okazawacho, Hodogaya-ku
TEL 045-331-1961
Email inagawa@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Yamamoto
Organization Yokohama Municipal hospital
Division name Department of anesthesiology
Zip code
Address 56 Okazawacho, Hodogaya-ku
TEL 045-331-1961
Homepage URL
Email craft_worker_y_takumi@yahoo.co.jp

Sponsor
Institute Yokohama Municipal hospital
Institute
Department

Funding Source
Organization Yokohama Municipal hospital
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
2014 Year 05 Month 20 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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 10 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
2014 Year 05 Month 20 Day
Last modified on
2014 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016195

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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