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PediatricNCT05956028

Efficacy of Ultrasound-guided Internal Jugular Vein Versus Supraclavicular Subclavian Vein Cannulation in Neonates and Infants Less Than 5 kg.

A study testing Ultrasound guided SCV cannulation and Ultrasound guided IJV cannulation in people with Pediatric and Anesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg. Read more about this study

Who is it for?
Ages 1 day to 12 months
Conditions the study is for
Pediatric, Anesthesia, Central Venous Catheter
What is being tested?
Ultrasound guided SCV cannulation and Ultrasound guided IJV cannulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteEgypt
Study dates
21 Jul 2023to 3 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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 day to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • All infants weighing less than 5 kg scheduled for major elective surgeries under general anesthesia.

Who cannot join

  • • Parents or legally authorized personnel refusal.
  • Previous trials of central venous cannulation in the last week.
  • Emergency surgery.
  • Coagulopathy (platelets less than 20.000 and or INR more than 1.5)
  • Infection at the proposed site for cannulation.
  • Inability to visualize vein correctly by the ultrasound.
  • Neck deformity or swelling in the proposed site of cannulation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo university hospitals

    Cairo, 11559

Other trials in Egypt

About this study

Official title: Efficacy of Ultrasound-guided Internal Jugular Vein Versus Supraclavicular Subclavian Vein Cannulation in Neonates and Infants Less Than 5 kg Undergoing Major Surgeries: a Prospective, Randomized Controlled Trial.

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg.

Read the detailed description

The aim of this study is to compare the effectiveness and safety of ultrasound- guided IJV and supraclavicular SCV cannulation in infants weighing less than 5 kg.

It is hypothesized that ultrasound guided supraclavicular SCV cannulation has a higher success rate compared to IJV cannulation.

Infants will be recruited into the trial during pre-operative assessment. Recruited infants will be randomly assigned to one of two groups in a 1:1 ratio; (group S) to receive ultrasound guided SCV cannulation and (group I) to receive ultrasound guided IJV cannulation. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes.

All infants will be anesthetized in accordance with the local policy of pediatric anesthesia unit in Abu El-Reesh pediatric hospital-Cairo university after ethics committee approval.

After preoperative examination and upon arrival to the operating room heart rate, noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using titration of sevoflurane in oxygen air mixture 60% (starting from 3% up to 8%) until the infant is put to sleep. After securing an intravenous line anesthesia will be completed with 1-2µg/kg of fentanyl and atracurium 0.5 mg/kg.

Induction of anesthesia will be performed by the attending senior anesthesia resident who has finished at least 2 years of residency (who is independent of the study team).

All cannulations will be performed by 2 pediatric anesthesiologists trained in US-guided central line placement each one has performed (more than 50 cannulations) before the study. Catheterization will be performed using a standard Seldinger technique under sterile conditions using high frequency (5-10 MHz) footprint ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA).

Before the procedure, IJV or SCV veins size, patency, and collapsibility with transducer pressure will be assessed using US probe. The cannulation side (right or left) choice and the central venous catheter size will be decided by the practitioner preference according to the patient's vein examination.

Group I:

The standard transverse out-of-plane approach will be used. Infants will be placed in the 10° Trendelenburg and a shoulder roll will be placed to extend the neck, which will be rotated about 30° to the opposite side of cannulation. The transducer will be placed in a transverse position over the patient's neck at the level of cricoid cartilage to identify IJV and common carotid artery (CCA) in short-axis view. The CCA and the IJV will be differentiated by pulsations of the artery and compressibility of the vein. The vein will be then centered on the screen. The skin puncture will be made in the center of the US image using a needle without syringe. The needle will be introduced at an angle of 60° to the skin surface, perpendicular to the transducer. The needle will be advanced toward IJV until an indentation of the anterior wall of the vein is noticed. If spontaneous blood flashback is obtained, the guide wire will be introduced into the vein and the procedure will be completed using Seldinger's technique. If no spontaneous blood return is observed despite clear visualization of the needle bevel in the vessel lumen on US, a syringe will be attached to the needle hub to aspirate blood and then the guide wire will be introduced into the vein and the procedure will be completed. The attempt will be considered successful when smooth insertion of the guidewire into the vein after confirmation of the site of the wire in the right atrium using intraoperative x ray. If blood could not be aspirated, the needle will be withdrawn, the attempt will be considered failed and another attempt will be made to a maximum of 3 attempts. If failure more than 3 attempts, another site will be chosen and the patient will be excluded from the study.

Group S:

The patient will be positioned with the neck extended and rotated 45° opposite to the cannulation side. A towel roll will be placed under the shoulders for adequate neck extension. The US probe will be placed against and above the clavicle to visualize the transversal view of carotid artery and IJV, and then will be slowly tilted against the infant's cheek, showing first the subclavian artery in longitudinal view, and then, more anterior, the SCV, lying on the pleural line.

After obtaining a satisfactory image of the SCV in the longitudinal axis, the needle will be introduced without syringe in an in-plane technique. If spontaneous blood flashback is obtained, the guide wire will be introduced into the vein and the procedure will be completed using Seldinger's technique. If no spontaneous blood return is observed despite clear visualization of the needle bevel in the vessel lumen on US, a syringe will be attached to the needle hub to aspirate blood and then the guide wire will be introduced into the vein and the procedure will be completed. The attempt will be considered successful when smooth insertion of the guidewire into the vein after confirmation of the site of the wire in the right atrium using intraoperative x ray. If blood could not be aspirated, the needle will be withdrawn, the attempt will be considered failed and another attempt will be made. If failure more than 3 attempts, another site will be chosen, and the patient will be excluded from the study.

Being tested
Ultrasound guided SCV cannulation, Ultrasound guided IJV cannulation
Keywords
ultrasound, central venous catheter, neonates, subclavian vein, internal jugular vein, anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided SCV cannulationProcedure or surgery

    receive ultrasound guided SCV cannulation

  • Ultrasound guided IJV cannulationProcedure or surgery

    receive ultrasound guided IJV cannulation

Study groups in NCT05956028
Study groupRoleWhat they receive
(group S)Experimentalreceive ultrasound guided subclavian vein cannulation
Receives: Procedure: Ultrasound guided SCV cannulation; Procedure: Ultrasound guided IJV cannulation
(group I)Active comparatorreceive ultrasound guided internal jugular vein cannulation
Receives: Procedure: Ultrasound guided SCV cannulation; Procedure: Ultrasound guided IJV cannulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The first attempt success rate.

    The attempt will be considered successful when smooth insertion of the guidewire into the vein.

    Measured: 1 hour

Secondary outcomes (2)
  1. Insertion time

    defined as time from the start of the needle puncture till smooth insertion of the guide wire

    Measured: 1 hour

  2. Number of puncture attempts.

    Number of puncture attempts.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start21 Jul 2023
  3. Primary completion3 Mar 2025
  4. Study completion3 Mar 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05956028
Sponsor's protocol ID
MD-159-2023
Status last verified
Mar 2025
First submitted
13 Jul 2023
Last updated
4 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sarhan K, Abdelgawad O, Abdelhamid B, El-Ashmawi H, Soliman D, Turki D, Salah H, Badry M. Efficacy of ultrasound-guided internal jugular vein versus subclavian vein cannulation in neonates and infants weighing less than 5 kg: a randomized controlled trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101681. doi: 10.1016/j.accpm.2025.101681. Epub 2025 Nov 17.

    PubMed 41260395

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided SCV cannulation and Ultrasound guided IJV cannulation in people with Pediatric and Anesthesia, run by Kasr El Aini Hospital 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The first attempt success rate. (time frame: 1 hour). 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 NCT05956028, 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 4 Mar 2025.

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