UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027843
Receipt number 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 22:05:52

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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 or person

Institute

Department of anesthesia, Saiseikai Shiga hospital,Shiga, JAPAN

Institute

Department

Personal name



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

Value
https://center6.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