InfantsNCT06862492
Open Surgical, Modified Seldinger's and US Techniques for Jugular Central Line Insertion in Infants
A study testing Open surgical cut down technique, Modified Seldinger's technique and Closed Ultrasound guided CVC insertion in people with Infants and Intensive Care Unit, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 hour to 18 months
- Conditions the study is for
- Infants, Intensive Care Unit, Central Venous Catheterization
- What is being tested?
- Open surgical cut down technique, Modified Seldinger's technique and Closed Ultrasound guided CVC insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2025to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Open Surgical, Modified Seldinger's and Ultrasound Guided Techniques for Jugular Central Line Insertion in Infants
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.
Read the 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
- Being tested
- Open surgical cut down technique, Modified Seldinger's technique, Closed Ultrasound guided CVC insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgical cut down techniqueDevice
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 techniqueDevice
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.
Closed Ultrasound guided CVC insertionDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| Open surgical technique group | Experimental | included 35 patients underwent Central venous catheterization insertion using Open surgical technique group Receives: Device: Open surgical cut down technique |
| Modified Seldinger's technique group | Experimental | included 35 patients underwent Central venous catheterization insertion Receives: Device: Modified Seldinger's technique |
| Ultrasound guided Central venous catheterization insertion group | Experimental | included 35 patients underwent closed ultrasound guided Central venous catheterization insertion Receives: Device: Closed Ultrasound guided CVC insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of cannulation
Central venous cannulations in pediatric patients using each technique
Measured: 20 minutes
Secondary outcomes (1)
Technique time
Measured: within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start21 Aug 2025 (estimated)
- Primary completion21 Aug 2025 (estimated)
- Study completion21 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Salah Eldin Amin, Tanta University
- Investigators
- Mohamed Amin, Demonstrator, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862492
- Sponsor's protocol ID
- 36264MS38/1/23
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from principle investigator
Publications
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.
PubMed 40611041
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Open Surgical, Modified Seldinger's and Ultrasound Guided Techniques for Jugular Central Line Insertion in Infants
- ClinicalTrials.gov ID
- NCT06862492
- Acronym / sponsor ID
- 36264MS38/1/23
- Conditions
- Infants, Intensive Care Unit, Central Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Aug 2025 (estimated)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 21 Aug 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open surgical technique group | Experimental | Device: Open surgical cut down techniqueincluded 35 patients underwent Central venous catheterization insertion using Open surgical technique group |
| Modified Seldinger's technique group | Experimental | Device: Modified Seldinger's techniqueincluded 35 patients underwent Central venous catheterization insertion |
| Ultrasound guided Central venous catheterization insertion group | Experimental | Device: Closed Ultrasound guided CVC insertionincluded 35 patients underwent closed ultrasound guided Central venous catheterization insertion |
Who may qualify
- Ages
- 1 hour to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open surgical cut down techniqueThe 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 | Open surgical technique group |
| Modified Seldinger's techniqueAfter 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 | Modified Seldinger's technique group |
| Closed Ultrasound guided CVC insertionUltrasound 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 . | Device | Ultrasound guided Central venous catheterization insertion group |
Primary outcome
success of cannulation
Time frame: 20 minutes
Central venous cannulations in pediatric patients using each technique
1 secondary outcome
Technique time
Time frame: within 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 40611041Salah 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.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Amin, Demonstrator principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgical cut down technique, Modified Seldinger's technique and Closed Ultrasound guided CVC insertion in people with Infants and Intensive Care Unit, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Amin, Demonstrator (0020 10 19848433, mohamed.salah.mms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of cannulation (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.