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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026223
Receipt No. 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

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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
Email 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
Email isao45@med.miyazaki-u.ac.jp

Sponsor
Institute Anesthesiology and Critical Care, Faculty of Medicine, University of Miyazaki
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030094

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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