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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027843
Receipt No. R000029178
Scientific Title Observational study for improvement of identifying the intervertebral space for indwelling an epidural catheter
Date of disclosure of the study information 2017/08/01
Last modified on 2017/12/06

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Basic information
Public title Observational study for improvement of identifying the intervertebral space for indwelling an epidural catheter
Acronym Study for better identification of intended intervertebral space in epidural anesthesia
Scientific Title Observational study for improvement of identifying the intervertebral space for indwelling an epidural catheter
Scientific Title:Acronym Study for better identification of intended intervertebral space in epidural anesthesia
Region
Japan

Condition
Condition Patients who received epidural anesthesia during surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The accuracy of identifying the intervertebral space during lower thoracic epidural anesthesia is unreliable. In our previous study, we determined a linear regression model with the body height as the independent variable, the length of the thoracic spine (to be exact, the distance between the seventh cervical spinous process and the twelfth thoracic spinous process) as the dependent variable. In this study, we will prototype a universal ruler that converts the body height to the thoracic length based on the primary equation. Next, when the intervertebral space is specified using the ruler, it is examined whether the specific accuracy improves over the conventional identification method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Using the prediction formula to calculate the length of the thoracic spine from body height, we determine the estimated position of the 12th thoracic spinous process of the participants. The epidural catheter is then indwelled from any intervertebral space with reference to that position. In the postoperative X - ray, the actual indwelling intervertebral space and the predicted intervertebral space are obtained. When the difference is 0, we determined as success, otherwise when deviation within the 1 vertebra,
we determined as intermediate success. Between the cases of epidural puncture using prediction formula and puncture using other methods, that is, puncture using conventional method, we find success ratio and intermediate success ratio. The main evaluation item is the success ratio and the intermediate success ratio. It is judged whether there is a statistically significant difference in the success ratio between the two groups.
Key secondary outcomes We will process the influence of the background factor of the patient and that of participating doctors on the predictive value by multivariate analysis. We use this result as a secondary evaluation item.

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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent surgery on the upper or lower abdomen performed by gastroenterologic surgery, obstetrics and gynecology, and urology under general anesthesia with epidural anesthesia
Key exclusion criteria 1 Patients with marked deformity and degeneration of the spine
2 Patients who are difficult to identify punctured intervertebra space due to poor visualization of epidural catheter and spine with postoperative radiograph
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Nozuchi
Organization Saiseikai Shiga Hospital
Division name dept. of anesthesia
Zip code
Address 2-4-1, Ohashi, Ritto city, Shiga, japan
TEL 077-552-1221
Email dob3gamma-mag01@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Shigematsu
Organization Saiseikai Shiga Hospital
Division name dept. of ethical comittie
Zip code
Address 2-4-1, Ohashi, Ritto city, Shiga, japan
TEL 077-552-1221
Homepage URL
Email dob3gamma-mag01@yahoo.co.jp

Sponsor
Institute Department of anesthesia, Saiseikai Shiga hospital,Shiga, JAPAN
Institute
Department

Funding Source
Organization Department of anesthesia, Saiseikai Shiga hospital,Shiga, JAPAN
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 済生会滋賀県病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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
The estimated intervertebral level and the confirmed intervertebral level confirmed perfectly between the 2 groups of the conventional method (group C) and predictive formula usage group (group S) were 32.2% for group C and 32.2% and 54.1% for group S(p = 0.00176). On the other hand, the concordance rate allowed up to +-1 vertebral discrepancy was 98.4% (p = 0.000195) in S group versus 76.3% in C group.
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
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 11 Month 01 Day
Date trial data considered complete
2017 Year 11 Month 01 Day
Date analysis concluded
2017 Year 11 Month 10 Day

Other
Other related information We obtain presumed thoracic length of the scheduled surgery patient by using the prediction formula that estimates the total length of the thoracic vertebra from the body height obtained by our previous study. Participating anesthetists select the arbitrary thoracic intervertebral level as the puncture site of epidural anesthesia with reference to that distance and describe it as the predicted intervertebral space. Postoperatively we obtain an actual puncture intervertebral space with an X - ray photograph. We calculate the degree of coincidence between the predicted intervertebral space and actual vertebral space and demonstrate that the accuracy of puncture vertebrae improvement by this method is better than before.

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2017 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029178

Research Plan
Registered date File name
2017/12/06 研究計画書(移行部推定).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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