UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation of appropriate peripheral venous catheter placement by microbubble detection after normal saline administration using ultrasonography in pediatric patients: a randomized controlled trial
Acronym	Confirmation of appropriate peripheral venous catheter placement by microbubble detection after normal saline administration using ultrasonography in pediatric patients: a randomized controlled trial
Scientific Title	Confirmation of appropriate peripheral venous catheter placement by microbubble detection after normal saline administration using ultrasonography in pediatric patients: a randomized controlled trial
Scientific Title:Acronym	Confirmation of appropriate peripheral venous catheter placement by microbubble detection after normal saline administration using ultrasonography in pediatric patients: a randomized controlled trial
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In pediatric intensive care unit, we randomly allocated patients in two groups. In ultrasound group, we perform microbubble test (MBT) as follows. We visualize patients' right atrium by cardiac ultrasonography (subcostal or apical four chamber view) and inject normal saline thorough peripherally venous catheters, which are already or newly inserted. We investigate whether microbubble is confirmed in right atrium using ultrasonography. In control group, we perform smooth injection test (SIT) as follows. We inject normal saline thorough peripherally venous catheters, and investigate whether injection is smoothly performed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate which both tests are positive in case peripheral venous catheter was appropriately positioned intravenous.
Key secondary outcomes	The rate which both tests are negative in case peripheral venous catheter was positioned extravenous.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	In ultrasound group, we perform microbubble test (MBT) as follows. We visualize patients' right atrium by cardiac ultrasonography (subcostal or apical four chamber view) and inject normal saline thorough peripherally venous catheters, which are already or newly inserted. We investigate whether microbubble is confirmed in right atrium using ultrasonography.
Interventions/Control_2	In control group, we perform smooth injection test (SIT) as follows. We inject normal saline thorough peripherally venous catheters, and investigate whether injection is smoothly performed.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Pediatric patients whose body weights are under 15kg, admit to PICU of Osaka Women's and Children's hospital, and peripheral venous catheter were newly or already inserted.
Key exclusion criteria	Patients whose parents do not agree with this study. Vasoactive agents are continuously administered through the peripheral venous catheter. Appropriate four chamber view cannot be obtained. Volume injection is restricted. Hemodynamic status is unstable. Patients who underwent Glenn operation or Fontan operation. Anatomical abnormality of Vena cava.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Takeshita
Organization	Osaka Women's and Children's Hospital
Division name	Department of Intensive Care Medicine
Zip code	5941101
Address	840 Murodo-cho, Izumi, Osaka 594-1101
TEL	0725-56-1220
Email	t-k-s-t@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Takeshita
Organization	Osaka Women's and Children's Hospital
Division name	Department of Intensive Care Medicine
Zip code	5941101
Address	840 Murodo-cho, Izumi, Osaka 594-1101
TEL	0725-56-1220
Homepage URL
Email	t-k-s-t@koto.kpu-m.ac.jp

Sponsor
Institute	Osaka Women's and Children's Hospital, Department of Intensive Care Medicine
Institute
Department

Funding Source
Organization	None
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	Osaka Women's and Children's Hospital
Address	840 Murodo-cho, Izumi, Osaka
Tel	0725561220
Email	t-k-s-t@koto.kpu-m.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	2018 Year 06 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	300
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	2018 Year 06 Month 22 Day
Date of IRB	2018 Year 06 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 25 Day
Last follow-up date	2020 Year 03 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	2018 Year 06 Month 25 Day
Last modified on	2020 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037786