UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022864
Receipt number R000026348
Scientific Title Efficacy of Mill Suss-guided radial artery catheterization in eldery patients.
Date of disclosure of the study information 2016/06/27
Last modified on 2019/12/27 12:33:22

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Basic information

Public title

Efficacy of Mill Suss-guided radial artery
catheterization in eldery patients.

Acronym

Efficacy of Mill Suss-guided radial artery
catheterization in eldery patients.

Scientific Title

Efficacy of Mill Suss-guided radial artery
catheterization in eldery patients.

Scientific Title:Acronym

Efficacy of Mill Suss-guided radial artery
catheterization in eldery patients.

Region

Japan


Condition

Condition

The patients requirements for artery catheterization

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of Ultrasound-guided and Ultrasound
-guided with Mill Suss radial artery
catheterization in eldery patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

First-attempt success rate of radial artery catheterization

Key secondary outcomes

The number of attempts to success of radial artery catheterization, The time to success of radial artery cathterization, the difficulty ofcatheterization, and complications


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Echo group: Get the concent from the patients
one day before operation and arterial catheterization operation day.

Interventions/Control_2

Echo with Mill Suss group:Get the concent from the patients one day before operation and arterial catheterization operation day.

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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who are ASA PS 1-3.

Key exclusion criteria

Dialysis patients
Peripheral artery disease patients

Target sample size

56


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Maruyama

Organization

Shinshu university school of medicine

Division name

The department of anesthesiology resuscitology

Zip code

390-8621

Address

Matsumoto, Nagano Prefecture Asahi 3-1-1

TEL

0263372670

Email

y5maruyama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Maruyama

Organization

Shinshu university school of medicine

Division name

The department of anesthesiology resuscitology

Zip code

390-8621

Address

Matsumoto, Nagano Prefecture Asahi 3-1-1

TEL

0263372670

Homepage URL


Email

y5maruyama@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu university school

Institute

Department

Personal name



Funding Source

Organization

Shinshu university school

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

The department of anesthesiology resuscitology,shinshu university school of medicine

Address

Matsumoto, Nagano Prefecture Asahi 3-1-1

Tel

0263372670

Email

y5maruyama@shinshu-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



Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 27 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

52

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

No longer recruiting

Date of protocol fixation

2016 Year 06 Month 06 Day

Date of IRB

2016 Year 06 Month 27 Day

Anticipated trial start date

2016 Year 06 Month 27 Day

Last follow-up date

2021 Year 06 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 23 Day

Last modified on

2019 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026348


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name