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Open Surgical, Modified Seldinger's and US Techniques for Jugular Central Line Insertion in Infants

T

Tanta University

Status

Not yet enrolling

Conditions

Central Venous Catheterization
Intensive Care Unit
Infants

Treatments

Device: Open surgical cut down technique
Device: Modified Seldinger's technique
Device: Closed Ultrasound guided CVC insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT06862492
36264MS38/1/23

Details and patient eligibility

About

The aim of this study was to compare the three approaches: open technique, modified Seldinger's technique and closed ultrasound-guided Central venous catheterization insertion for central line insertion in infancy as regards safety, success of cannulation, technique time, and preservation of the patency of the internal jugular vein.

Full description

Central venous catheterization is an essential technique in the intensive care units , for the administration of life-saving treatments including total parenteral nutrition, nutritional support, and intravenous medication. The internal jugular vein is often chosen because of its relatively larger size than the subclavian vein, lower risk of complications, and easy compressibility in case of bleeding. To facilitate Central venous catheterization, ultrasound guidance over anatomical guidance in closed techniques has been introduced bringing increased success rates, decreased catheterization times, and reduced complications.

Open surgical insertion is a common method of tunneled catheter implantation in the past, but the percutaneous approach has recently gained more popularity . The modified Seldinger's insertion technique is a catheter over guide wire technique, based on the original Seldinger's technique, and has not been widely adopted in Intensive care units. However, the modified Seldinger's technique has been successfully introduced into Intensive care units, and it is now used as the only technique for peripherally inserted central venous catheter insertion .

Central venous catheterization have become a mandatory part of clinical management in a variety of clinical circumstances in pediatric age groups. It allows resuscitation for intravascular fluid depletion and access for vasoactive medications and antibiotics, and it provides a means for hemodynamic monitoring and pacing. US guided closed technique is the updated use for insertion of IJV catheterization because it can both increase the success rate and decrease the complications related to Central venous catheterization placement

Enrollment

35 estimated patients

Sex

All

Ages

1 hour to 18 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1-patients needed Central venous catheterization insertion in the internal jugular vein for medical or surgical causes.

2- patients with age ranging from birth till two years

Exclusion criteria

  • 1- femoral or subclavian Central venous catheterization insertion. 2- patients with thrombosed internal jugular vein . 3- patients with previous Central venous catheterization insertion. 4- those with malignant conditions

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 3 patient groups

Open surgical technique group
Experimental group
Description:
included 35 patients underwent Central venous catheterization insertion using Open surgical technique group
Treatment:
Device: Open surgical cut down technique
Modified Seldinger's technique group
Experimental group
Description:
included 35 patients underwent Central venous catheterization insertion
Treatment:
Device: Modified Seldinger's technique
Ultrasound guided Central venous catheterization insertion group
Experimental group
Description:
included 35 patients underwent closed ultrasound guided Central venous catheterization insertion
Treatment:
Device: Closed Ultrasound guided CVC insertion

Trial contacts and locations

1

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Central trial contact

Mohamed Amin, Demonstrator

Data sourced from clinicaltrials.gov

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