UMIN-CTR Clinical Trial

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
Email	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
Email	takahashito-tky@umin.ac.jp

Sponsor
Institute	Department of Advanced Nursing Technology, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034094