UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Isao Tsuneyoshi
Organization	University of Miyazaki
Division name	Department of Anesthesiology and Critical Care, Faculty of Medicine
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	Isao Tsuneyoshi
Organization	University of Miyazaki
Division name	Anesthesiology and Critical Care, Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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