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

NCT06862492 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-03-11

No results posted yet for this study

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.

Conditions

  • Infants
  • Intensive Care Unit
  • Central Venous Catheterization

Interventions

DEVICE

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

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.

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 .

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Mohamed Amin, Demonstrator · Tanta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2025-08-21
Completion
2025-08-21

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862492 on ClinicalTrials.gov