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

NCT ID: NCT06862492

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2025-08-21

Brief Summary

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.

Detailed 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

Conditions

Infants; Intensive Care Unit; Central Venous Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Open surgical technique group

included 35 patients underwent Central venous catheterization insertion using Open surgical technique group

Group Type: EXPERIMENTAL

Open surgical cut down technique

Intervention Type: DEVICE

The technique was performed following the descriptions of Farhadi et al. The infant was positioned in 30° (Trendelenburg's position), with a roll under his shoulders for neck extension and rotated to contralateral side of the surgical side to expose the incision site. Incision was done under sedation and pulse oximeter to monitor the oxygen saturation during the technique.

Under complete aseptic technique, a small transverse incision 1cm was made on triangle bordered by the clavicle inferiorly and by the sternal and clavicular heads of the sternomastoid muscle medially and laterally. With blunt dissection we separate the two heads of the sternomastoid exposing the internal jugular vein .

Then internal jugular vein cut down was performed and catheter inserted through it, all internal jugular vein venotomies were repaired as needed by 6/0 Polypropylene (Prolene®) suture and the wound was closed by absorbable polyglactin (Vicryl) suture

Modified Seldinger's technique group

included 35 patients underwent Central venous catheterization insertion

Group Type: EXPERIMENTAL

Modified Seldinger's technique

Intervention Type: DEVICE

After proximal and distal control of the vein, a 24-G. cannula was carefully inserted directly to the internal jugular vein . The guidewire was inserted through the cannula, then the cannula was removed. A size 4-5 French short length catheter was passed and brought out through the guidewire, then the guidewire was removed. The wound was closed after the correct catheter position and good haemostasis was obtained; the area was covered with sterile dressing.

Ultrasound guided Central venous catheterization insertion group

included 35 patients underwent closed ultrasound guided Central venous catheterization insertion

Group Type: EXPERIMENTAL

Closed Ultrasound guided CVC insertion

Intervention Type: DEVICE

Ultrasound probe was connected to ultrasound unit and focused with ultrasonic gel and wrapped in a sterile plastic sheath. By wrapping the transducer in a sterile sheath, the probe place perpendicular to the long axis of the vessel, standard US two-dimensional (2D) imaging was used to visualize the vein in the short-axis view as a circle. Catheterization was performed under continuous dynamic observation of real-time 2D images. Insertion needle was advanced through the skin under US guidance into the internal jugular vein . A guidewire was then placed through the needle into the vein, and the needle was removed. Then catheter was inserted over the wire into internal jugular vein .

Interventions

Open surgical cut down technique

The technique was performed following the descriptions of Farhadi et al. The infant was positioned in 30° (Trendelenburg's position), with a roll under his shoulders for neck extension and rotated to contralateral side of the surgical side to expose the incision site. Incision was done under sedation and pulse oximeter to monitor the oxygen saturation during the technique.

Under complete aseptic technique, a small transverse incision 1cm was made on triangle bordered by the clavicle inferiorly and by the sternal and clavicular heads of the sternomastoid muscle medially and laterally. With blunt dissection we separate the two heads of the sternomastoid exposing the internal jugular vein .

Then internal jugular vein cut down was performed and catheter inserted through it, all internal jugular vein venotomies were repaired as needed by 6/0 Polypropylene (Prolene®) suture and the wound was closed by absorbable polyglactin (Vicryl) suture

Intervention Type: DEVICE

Modified Seldinger's technique

After proximal and distal control of the vein, a 24-G. cannula was carefully inserted directly to the internal jugular vein . The guidewire was inserted through the cannula, then the cannula was removed. A size 4-5 French short length catheter was passed and brought out through the guidewire, then the guidewire was removed. The wound was closed after the correct catheter position and good haemostasis was obtained; the area was covered with sterile dressing.

Intervention Type: DEVICE

Closed Ultrasound guided CVC insertion

Ultrasound probe was connected to ultrasound unit and focused with ultrasonic gel and wrapped in a sterile plastic sheath. By wrapping the transducer in a sterile sheath, the probe place perpendicular to the long axis of the vessel, standard US two-dimensional (2D) imaging was used to visualize the vein in the short-axis view as a circle. Catheterization was performed under continuous dynamic observation of real-time 2D images. Insertion needle was advanced through the skin under US guidance into the internal jugular vein . A guidewire was then placed through the needle into the vein, and the needle was removed. Then catheter was inserted over the wire into internal jugular vein .

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mahmoud Salah Eldin Amin

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Amin, Demonstrator

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Central Contacts

Mohamed Amin, Demonstrator

Role: CONTACT

mohamed.salah.mms@gmail.com

0020 10 19848433

References

Salah Eldin MM, Shehata SMK, Shehata MA, Elhaddad AA. Comparing open surgical, SELDINGER'S technique with surgical isolation of the vein and ultrasound guided techniques for jugular central line insertion in infants: a randomized clinical trial. BMC Surg. 2025 Jul 3;25(1):280. doi: 10.1186/s12893-025-02988-5.

Reference Type: DERIVED

PMID: 40611041 (View on PubMed)

Other Identifiers

36264MS38/1/23

Identifier Type: -

Identifier Source: org_study_id