UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033958 |
|---|---|
| Receipt number | R000038733 |
| Scientific Title | Ultrasound confirmation of peripheral venous catheter placement. |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2023/09/05 00:15:04 |
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Basic information
Public title
Ultrasound confirmation of peripheral venous catheter placement.
Acronym
Ultrasound confiration of peripheral intravenous line placement.
Scientific Title
Ultrasound confirmation of peripheral venous catheter placement.
Scientific Title:Acronym
Ultrasound confiration of peripheral intravenous line placement.
Region
| Japan |
Condition
Condition
Body surface anormay such as Inguinal hernia, umbilical hernia, and extrimity's anormaly
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how much volume is needed to detect if the peripheral venous catheter is in the vein with ultrasound.
Basic objectives2
Others
Basic objectives -Others
To confirm that the volume need to detect if the peripheral venous catheter is in is less than 5-10ml which was reported previously.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The volume to detect if the peripheral venous catheter is in the vein with ultrasound.
Key secondary outcomes
The volume to detect if the peripheral venous catheter is in is less than 5-10ml which was reported previously.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Giving fluid less than 5 ml after placement of peripheral vesous catheter.The veous at axilary will be observed during giving the fluid.
Interventions/Control_2
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
| 3 | months-old | < |
Age-upper limit
| 72 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ASA PS 1 or 2 , scheduled for elective surgery.
Key exclusion criteria
Patients who have peripheral intravenous catheter preoperatively.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mineto |
| Middle name | |
| Last name | Kamata |
Organization
Saitama Children's Medical Center
Division name
Department of Anesthesiology
Zip code
330-8777
Address
1-2 Shintoshin, Chuo-ku, Saitama 330-8777
TEL
048-601-2200
Mineto.Kamata@gmail.com
Public contact
Name of contact person
| 1st name | Mineto |
| Middle name | |
| Last name | Kamata |
Organization
Saitama Children's Medical Center
Division name
Department of Anesthesiology
Zip code
330-0777
Address
1-2 Shintoshin, Chuo-ku, Saitama 330-8777
TEL
048-601-2200
Homepage URL
Mineto.Kamata@gmail.com
Sponsor or person
Institute
Saitama Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Children's Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Children's Medical Center
Address
1-2 Shintoshin, Chuo-ku, Saitama 330-8777
Tel
048-601-2200
Mineto.Kamata@gmail.com
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 | 08 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038733
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038733
Number of participants that the trial has enrolled
30
Results
The study cohort included 30 patients aged 0.3-5.5 (2.6+-1.6) years. Color change was noted in all the patients. The average volume was 1.40+-0.36 mL (95% confidence interval [CI], 1.27-1.54; P<0.001), which was significantly correlated with age, with a correlation coefficient of 0.435 (95% CI, 0.09-0.69; P=0.0163).
Results date posted
| 2023 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children under 6 years old with American Society of Anesthesiologists Physical Status (ASA-PS) 1 or 2 who underwent scheduled surgery were enrolled in this study
Participant flow
In all 30 patients for whom parental consent was obtained, venous channeling could be confirmed by the color Doppler test.
Adverse events
N/A
Outcome measures
A volume of 1.4 mL of normal saline may be sufficient to confirm intravenous access in children under 6 years of age using the color flow infection test.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038733
