- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03530618
Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children
September 13, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital
Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- surgery under general anesthesia
- require central venous catheterization
Exclusion Criteria:
- central vein anomaly
- hematoma in central vein
- catheterization site infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Flexible tip straight guidewire
|
Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization
|
Experimental: J-tip guidewire
|
Use a J tip straight guidewire for ultrasound-guided central venous catheterization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First successful central venous catheterization rate
Time Frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
|
Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first puncture of central vein
Time Frame: Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
|
Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
|
Time to guide wire insertion
Time Frame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
|
Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
|
Total time to central venous catheterization
Time Frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
|
Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
|
Number of central vein puncture trial
Time Frame: up to 5 times, an expected average observation time of 30 seconds
|
up to 5 times, an expected average observation time of 30 seconds
|
Number of guide wire insertion trial
Time Frame: up to 5 times, an expected average observation time of 90 seconds
|
up to 5 times, an expected average observation time of 90 seconds
|
First successful central vein puncture rate
Time Frame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
|
Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
|
First successful guide wire insertion rate
Time Frame: Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
|
Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jin-Tae Kim, Professor, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2018
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
May 8, 2018
First Submitted That Met QC Criteria
May 8, 2018
First Posted (Actual)
May 21, 2018
Study Record Updates
Last Update Posted (Actual)
September 20, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- H-1803-150-935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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