UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029850 |
|---|---|
| Receipt number | R000034094 |
| Scientific Title | Intervention study of peripheral intravenous catheter failure prevention method |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2021/05/10 10:27:26 |
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Basic information
Public title
Intervention study of peripheral intravenous catheter failure prevention method
Acronym
Intervention study of peripheral intravenous catheter failure prevention method
Scientific Title
Intervention study of peripheral intravenous catheter failure prevention method
Scientific Title:Acronym
Intervention study of peripheral intravenous catheter failure prevention method
Region
| Japan |
Condition
Condition
intravenous infusion
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify to prevent the occurrence of Peripheral intravenous catheter (PIVC) failure by care conducted by nurses who received interventional education including visualization assessment using ultrasonic inspection equipment to compare with carrying out conventional care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of premature removal of peripheral intravenous catheter
Key secondary outcomes
Peripheral intravenous catheter survival analyse .
Incidence of complications (phlebitis, extravasation, accidental withdrawal, obstruction, infection etc.)
Incidence of symptomatic signs (pain, redness, swelling, hot feeling, induration, etc.)
Ultrasonic examination findings at the time of removal (peripheral venous catheter position, intravascular thrombus, blood vessel wall thickening, tissue edema, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Definition of intervention.
The intervention group is a group in which researchers provide indications of care sets, and the nurses who got explanations place and manage peripheral vein catheters like as care bundles. In addition, nurses may receive assistance of care by researchers (confirmation / readjustment of catheter position by ultrasonic examination) in some cases.
Intervention is to receive care education for nurses by researcher. Education is about receiving lectures and briefing sessions about 30 minutes about its contents and implementation method.
Interventions/Control_2
The control group is a group that performs conventional care according to the manual prescribed in the targeted hospital.
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
Patient
Patient hospitalized for the targeted two words in The University of Tokyo Hospital Inpatient Building A, and is infused using an indwelling catheter from a peripheral vein.
Nurse
Person who belongs to any department of intervention or control and who inserts and manages a peripheral vein.
Key exclusion criteria
Patient
Patients undergoing cancer chemotherapy, and minors
Nurse
None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Ryoko |
| Middle name | |
| Last name | Murayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Advanced Nursing Technology
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9531
rymurayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gerontological Nursing/Wound Care Management
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3439
Homepage URL
takahashito-tky@umin.ac.jp
Sponsor or person
Institute
Department of Advanced Nursing Technology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion of science
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
TERUMO CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
7-3-1 Hongo, Bunyo-ku, Tokyo
Tel
0358411084
ethics@m.u-tokyo.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
| 2017 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.1038/s41598-019-56873-2
Number of participants that the trial has enrolled
422
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
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034094
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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