Central Venous Catheterization in Children: Jugulo-subclavian Venous Confluence Versus Internal Jugular Vein
The goal of this study was to compare ultrasound-guided central venous catheterization via the IJV to the JSVC using the supraclavicular approach in children. The main questions it aims to answer are:
- Are ultrasound-guided central venous catheterization via the internal jugular vein (IJV) and via the jugular-supraclavicular vein (JSVC) using the supraclavicular approach equivalent in terms of procedural efficacy (e.g., success rate, time to cannulation) in children?
- Are these two techniques comparable in terms of safety (e.g., complication rates, adverse events) in pediatric patients?
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tunis, Tunisia
- Bechir Hamza Children Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 1 month to 14 years, admitted to the pediatric intensive care unit of the anesthesiology and critical care department at Béchir Hamza Children's Hospital in Tunis, or scheduled for major elective surgery under general anesthesia requiring central venous catheter placement.
Exclusion Criteria:
- Patients in whom ultrasound revealed a thrombotic formation in the vein.
- Patients for whom the vein could not be adequately visualized on ultrasound
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: IVJ group
Group undergoing catheterization of the internal jugular vein using an out-of-plane technique
|
ultrasound guided central venous catheterization in children
|
|
Other: JSVC group
Group undergoing catheterization of the jugulosubclavian confluent via the supraclavicular in-plane technique
|
ultrasound guided central venous catheterization in children
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
first-attempt Success rate
Time Frame: From the day of randomization until radiographic confirmation of central venous catheter position, assessed up to 6 hours.
|
Obtaining blood reflux from the target vein on the first attempt
|
From the day of randomization until radiographic confirmation of central venous catheter position, assessed up to 6 hours.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 072025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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