UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014011 |
|---|---|
| Receipt number | 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 18:07:19 |
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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
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
craft_worker_y_takumi@yahoo.co.jp
Sponsor or person
Institute
Yokohama Municipal hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016195
