UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045539
Receipt number R000051995
Scientific Title A study on the comparison of insertion failure of new and existing peripheral intravenous needles in emergency room
Date of disclosure of the study information 2021/09/22
Last modified on 2023/02/27 14:47:47

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Basic information

Public title

A study on the comparison of insertion failure of new and existing peripheral intravenous needles in emergency room

Acronym

A study on the comparison of insertion failure of new and existing peripheral intravenous needles in emergency room

Scientific Title

A study on the comparison of insertion failure of new and existing peripheral intravenous needles in emergency room

Scientific Title:Acronym

A study on the comparison of insertion failure of new and existing peripheral intravenous needles in emergency room

Region

Japan


Condition

Condition

Patients who are transported to Jichi Medical University Saitama Medical Center during weekdays.

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether the use of newly developed needles decreases the rate of failure of insertion compared to the use of existing needles in emergency room.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Failure rate of insertion of peripheral venous catheter during initial insertion

Key secondary outcomes

Number of punctures before successful insertion of peripheral venous catheter


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria.
(1) The patient was transported to Jichi Medical University Saitama Medical Center.
(2) The staff of department of emergency room responded during the weekday.
(3) Consecutive patients from the first patient during the weekday (minimum of two, no upper limit).
4) Second-year resident, senior resident, or nurse inserted the peripheral intravascular catheter.

Key exclusion criteria

Patients who meet any of the following criteria.
(1) Under 18 years old.
(2) Cardiopulmonary arrest.
(3) Maintenance dialysis.
(4) Transported by tertiary emergency triage.
(5) Additional peripheral intravascular catheter inserted in an emergency.
(6) Peripheral intravascular catheter was not inserted.

Target sample size

522


Research contact person

Name of lead principal investigator

1st name Hideto
Middle name
Last name Yasuda

Organization

Jichi Medical University Saitama Medical Center

Division name

department of emergency medicine

Zip code

330-0834

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan

TEL

048-647-2111

Email

yasudahideto@me.com


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Kishihara

Organization

Jichi Medical University Saitama Medical Center

Division name

department of emergency medicine

Zip code

330-0834

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan

TEL

048-647-2111

Homepage URL


Email

duke.amber.eyes6@gmail.com


Sponsor or person

Institute

Jichi Medical University Saitama Medical Center

Institute

Department

Personal name



Funding Source

Organization

TERUMO CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Jichi Medical University Saitama Medical Center

Address

1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama, Japan

Tel

048-647-2111

Email

s-suishin@jichi.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

2021 Year 09 Month 22 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

522

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

Completed

Date of protocol fixation

2021 Year 09 Month 22 Day

Date of IRB

2022 Year 03 Month 22 Day

Anticipated trial start date

2022 Year 01 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None.


Management information

Registered date

2021 Year 09 Month 22 Day

Last modified on

2023 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051995


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name