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
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
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
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
