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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033134
Receipt No. R000037786
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
Date of disclosure of the study information 2018/06/25
Last modified on 2018/06/25

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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
Middle name
Last name Jun Takeshita
Organization Osaka Women's and Children's Hospital
Division name Department of Intensive Care Medicine
Zip code
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
Middle name
Last name Jun Takeshita
Organization Osaka Women's and Children's Hospital
Division name Department of Intensive Care Medicine
Zip code
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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 22 Day
Date of IRB
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
2018 Year 06 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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