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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033958
Receipt No. R000038733
Scientific Title Ultrasound confirmation of peripheral venous catheter placement.
Date of disclosure of the study information 2018/08/30
Last modified on 2019/03/14

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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
Email 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
Email Mineto.Kamata@gmail.com

Sponsor
Institute Saitama Children's Medical Center
Institute
Department

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
Email 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
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 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 07 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038733

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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