UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026223 |
|---|---|
| Receipt number | R000030094 |
| Scientific Title | A study on differences between the distance from the skin to the thoracic epidural space and from the skin to the thoracic cavity in CT images |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2017/02/20 15:49:37 |
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Basic information
Public title
A study on differences between the distance from the skin to the thoracic epidural space and from the skin to the thoracic cavity in CT images
Acronym
Differences between the distance from the skin to the thoracic epidural space and from the skin to the thoracic cavity in CT images
Scientific Title
A study on differences between the distance from the skin to the thoracic epidural space and from the skin to the thoracic cavity in CT images
Scientific Title:Acronym
Differences between the distance from the skin to the thoracic epidural space and from the skin to the thoracic cavity in CT images
Region
| Japan |
Condition
Condition
40 adult patients examined using thoracic CT scanning at surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measured the distance from the skin to the epidural space and the thoracic cavity on the route for thoracic epidural catheterization in computed tomography (CT) images and assessed how structurally different the distance was.
Basic objectives2
Others
Basic objectives -Others
pneumothorax and catheter insertion into the thoracic cavity are avoided at puncture.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
There was no significant difference between the distance from the skin to the epidural space and from the skin to the ipsilateral thoracic cavity in patients of either sex. On the other hand, the distance to the contralateral thoracic cavity was significantly longer than to the epidural space.Data from November 2014 and June 2015.
Key secondary outcomes
The distance from the skin to the epidural space and to the ipsilateral thoracic cavity was significantly shorter in the females than in the males.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients meeting the inclusion criteria of age: 20 years and over, height: standard height, and weight: standard weight were selected as the subjects for the present study to investigate distance differences in patients with a standard Japanese physique.
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Tsuneyoshi |
Organization
University of Miyazaki
Division name
Department of Anesthesiology and Critical Care, Faculty of Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL
0985-85-9357
isao45@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Tsuneyoshi |
Organization
University of Miyazaki
Division name
Anesthesiology and Critical Care, Faculty of Medicine
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
TEL
0985-85-9357
Homepage URL
isao45@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Anesthesiology and Critical Care, Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Because the distance from the skin to the thoracic cavity on the puncture side was nearly the same as the distance from the skin to the epidural space in the paramedian approach, it has become clear that even when puncture for thoracic epidural anesthesia is performed at an angle for the paramedian approach, the needle might actually be inserted by accident at an angle similar to that for the median approach due to inadequate body positioning and spinal deformation, resulting in an increased risk of accidental perforation of the ipsilateral thoracic cavity.
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
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 25 | Day |
Other
Other related information
It is also suggested that the risk of perforation of the thoracic cavity is higher in females.
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030094
