UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042247
Receipt number R000048238
Scientific Title Prediction of the depth and trajectory of epidural needle by the preprocedural CT and ultrasound image.
Date of disclosure of the study information 2020/10/30
Last modified on 2020/10/27 08:07:16

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Basic information

Public title

Can preprocedural CT image and ultrasound image correctly predict the depth and trajectory of epidural needle?

Acronym

Prediction of the depth and trajectory of epidural needle

Scientific Title

Prediction of the depth and trajectory of epidural needle by the preprocedural CT and ultrasound image.

Scientific Title:Acronym

Ultrasound guidance of epidural block

Region

Japan


Condition

Condition

Thoracic, intraabdominal and hip joint surgery

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Obstetrics and Gynecology Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Accuracy of the estimated depth and trajectory of epidural needle by the preprocedural CT and ultrasound image

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Accuracy of the estimated depth and trajectory of epidural needle by the preprocedural CT and ultrasound image.

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing surgery with epidural block
Patients with CT image at block level within 6 months before surgery.

Key exclusion criteria

Patients with the history of allergic reaction to local anesthetics.
Patients with inappropriate duration of anticoagulants and/or antiplatelet medications before surgery.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshifumi
Middle name
Last name Kotake

Organization

Toho University Ohashi Medical Center

Division name

Department of Anesthesiology

Zip code

153-8515

Address

2-22-36 Ohashi, Meguro, Tokyo, Japan

TEL

03-3468-1251

Email

ykotake@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Kawamura

Organization

Toho University Ohashi Medical Center

Division name

Institutional review board

Zip code

153-8515

Address

2-22-36 Ohashi, Meguro, Tokyo, Japan

TEL

03-3468-1251

Homepage URL

http://www.lab.toho-u.ac.jp/med/ohashi/anesth/

Email

ohashi.rinri@ext.toho-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Toho University Ohashi Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Institutional review board, Toho University Ohashi Medical Center

Address

2-22-36 Ohashi, Meguro, Tokyo, Japan

Tel

03-3468-1251

Email

ohashi.rinri@ext.toho-u.ac.jp


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

東邦大学医療センター大橋病院(東京都)
Toho University Ohashi Medical Center (Tokyo)


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 30 Day


Related information

URL releasing protocol

http://www.lab.toho-u.ac.jp/med/ohashi/anesth/

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Preinitiation

Date of protocol fixation

2020 Year 08 Month 31 Day

Date of IRB

2020 Year 09 Month 30 Day

Anticipated trial start date

2020 Year 11 Month 02 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 04 Month 30 Day

Date trial data considered complete

2023 Year 04 Month 30 Day

Date analysis concluded

2023 Year 07 Month 31 Day


Other

Other related information

(1) Prediction of epidural needle trajectory and depth with preoperative CT image.
(2) Prediction of epidural needle trajectory and depth with preoperative ultrasound image
(3) Recording of actual trajectory and depth of epidural needle.
(4) Evaluation of accuracy derived from CT image and ultrasound image against actual trajectory and depth


Management information

Registered date

2020 Year 10 Month 27 Day

Last modified on

2020 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048238


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name