UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033134 |
|---|---|
| Receipt number | 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 | 2020/01/22 13:58:42 |
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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 | 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
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
t-k-s-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital, Department of Intensive Care Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037786
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