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

NCT06862492 | Not Yet Recruiting

• 1 other identifier: 36264MS38/1/23
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Infants; Intensive Care Unit; Central Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• success of cannulation

  Central venous cannulations in pediatric patients using each technique

  20 minutes

Secondary Outcomes (1)

• Technique time

  within 30 minutes

Study Arms (3)

Open surgical technique group

EXPERIMENTAL

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

Device: Open surgical cut down technique

Modified Seldinger's technique group

EXPERIMENTAL

included 35 patients underwent Central venous catheterization insertion

Device: Modified Seldinger's technique

Ultrasound guided Central venous catheterization insertion group

EXPERIMENTAL

included 35 patients underwent closed ultrasound guided Central venous catheterization insertion

Device: Closed Ultrasound guided CVC insertion

Interventions

Open surgical cut down technique 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

Open surgical technique group

Modified Seldinger's technique 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.

Modified Seldinger's technique group

Closed Ultrasound guided CVC insertion 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 .

Ultrasound guided Central venous catheterization insertion group

Eligibility Criteria

• Age: 1 Hour - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 1-patients needed Central venous catheterization insertion in the internal jugular vein for medical or surgical causes.
• patients with age ranging from birth till two years

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, 31527, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40611041 DERIVED

Study Officials

• Mohamed Amin, Demonstrator

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Amin, Demonstrator

CONTACT

0020 10 19848433; mohamed.salah.mms@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: August 21, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For one year
• Access Criteria: Statistical analysis was done using Statistical Package for the Social Sciences (SPSS) v27 (IBM©, Armonk, IL, USA). The Shapiro-Wilks test and histograms were used to evaluate the normality of the distribution of data. Quantitative parametric data were presented as mean and standard deviation (SD) and were analysed by one way ANOVA (F) test with post hoc test (Tukey). Quantitative non-parametric data were presented as median and interquartile range (IQR) and were analysed using Kruskal-Wallis test and/or Mann Whitney-test to compare each group. Qualitative variables were presented as frequency and percentage (%) and were analyzed utilizing the Chi-square test. A two tailed probability (P) value \<0.05 was considered statistically significant.

Locations

EG (1)