Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children
Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials
1 other identifier
interventional
88
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedStudy Start
First participant enrolled
September 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 20, 2021
September 1, 2021
2.8 years
May 8, 2018
September 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
First successful central venous catheterization rate
Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes
Secondary Outcomes (7)
Time to first puncture of central vein
Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
Time to guide wire insertion
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
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
up to 5 times, an expected average observation time of 30 seconds
Number of guide wire insertion trial
up to 5 times, an expected average observation time of 90 seconds
- +2 more secondary outcomes
Study Arms (2)
Flexible tip straight guidewire
EXPERIMENTALJ-tip guidewire
EXPERIMENTALInterventions
Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization
Use a J tip straight guidewire for ultrasound-guided central venous catheterization
Eligibility Criteria
You may qualify if:
- surgery under general anesthesia
- require central venous catheterization
You may not qualify if:
- central vein anomaly
- hematoma in central vein
- catheterization site infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Kim EH, Kang P, Song IS, Ji SH, Jang YE, Lee JH, Kim HS, Kim JT. Straight-tip guidewire versus J-tip guidewire for central venous catheterisation in neonates and small infants: A randomised controlled trial. Eur J Anaesthesiol. 2022 Aug 1;39(8):656-661. doi: 10.1097/EJA.0000000000001695. Epub 2022 Jul 7.
PMID: 35793466DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, Professor
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 21, 2018
Study Start
September 6, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
September 20, 2021
Record last verified: 2021-09