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OpenTrials
Completed

NCT Number: NCT06652490

Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for US Guided IJV Catheterization in Infants.

The investigators will measure and compare the rate of acute complications, success rate, number of attempts to successful cannulation between ultrasound-guided short axis approach and oblique axis approach during internal jugular venous catheterization in infants.

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Key information

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, Egypt, 11111

About this study

  • pre-procedure settings: The history will be obtained from patient's parents. Investigations will be checked to all patients as (complete blood picture and coagulation profile) to avoid coagulopathy and thrombocytopenia.

All patients will be attached to standard monitoring (blood pressure (non-invasive), heart rate, and pulse oximetry).

Groups:

Patients will be assigned randomly by using a computer -generated table of random numbers into two groups:

  • Group A (control group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is placed perpendicular to the venous anatomy in the SAX approach.
  • Group B (comparative group): ( n=25 ): CVL insertion in the right internal jugular vein using ultrasound. The US probe is aligned at 45° angulation?clockwise with the venous anatomy in the OAX approach.
  • procedure Settings: Monitor will be connected and pulse oximetry (SPO2), baseline non-invasive blood pressure (NIBP), heartrate (HR), electrocardiogram (ECG) will be obtained.

In this study, we will use US machine with small linear probe with frequency 5 - 10 Hz and the procedure will be held by the most senior Anaesthesiologist experience in pediatric central venous catheterization for at least 3 years.

The procedure will be held under aseptic condition, Using US, after GA in OR, the anatomical location and patency of the IJV will be assessed with the patient placed in the Trendelenburg position, with the head slightly rotated to the contralateral side. With all sterile precautions, a 4 french introducer needle mounted on a syringe is inserted into the IJV guided by real time US imaging. Once blood is freely aspirated, the US probe is set aside and the syringe removed from the needle. Then the guide wire will be advanced through the needle into the vessel and the catheter will be advanced using the Seldinger technique after guidewire position is confirmed with US. The guidewire will be then removed. Using US, placement of the catheter in the vein will confirmed following which the catheter will be secured in place using sutures. The position of the CVC wiil be also confirmed by a chest radiograph at the end of the procedure.

In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach.

In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 1 month and 12 months
  • Physical status: patients requiring CVC in their management

Exclusion criteria

  • patient's parents refuse to do the study
  • Coagulopathy (INR > 1.5, platelets count < 50.000), use of anti-coagulant or anti platelet therapy) (Sunny et al, 2022)
  • Infection, wounds or subcutaneous hematoma close to the puncture site
  • history of previous surgical intervention at the cannulation site
  • subcutaneous emphysema, penetrating neck trauma or cervical trauma

Treatment and study plan

Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.

Procedure

In the group A, The US probe will be placed perpendicular to the venous anatomy in the SAX approach.

In the group B, The US probe will be aligned at 45° angulation with the venous anatomy, and combined with an in plane needle insertion technique. The needle will be advanced from lateral to medial.

Primary outcomes

  1. Difference in the rate of acute complications between the two groups.

    Time frame: Post-procedure, through study completion (average 1 year)

    acute complications as posterior venous wall puncture (PVWP) (ultrasonographic identification of the needle tip or guidewire at any site deeper than the posterior wall of the IJV during cannulation attempts), skin and subcutaneous hematoma, arterial puncture (any pulsatile blood reflux through the needle observed during the procedure), pneumothorax, hemothorax and catheter misplacement (catheter tip identified at any place other than the superior vena cava in the control chest radiograph)

Secondary outcomes

  1. Difference in the rate of first successful cannulation attempt.

    Time frame: Post procedure, through study completion (average 1 year)

    first successful cannulation attempt (successful venous puncture and successful smooth insertion of guidewire from the first needle puncture without withdrawal of the needle)

  2. the flash time.

    Time frame: Post procedure, through study completion (average 1 year)

    time to completion flash time (The time interval between skin puncture and observing blood at the syringe hub)

  3. the number of needle redirection.

    Time frame: Post procedure, through study completion (average 1 year)

    number of needle redirection (redirection of the needle without complete withdrawal of the needle)

  4. unsuccessful cannulation.

    Time frame: Post procedure, through study completion (average 1 year)

    unsuccessful cannulation (a cannulation is considered unsuccessful if it had to be performed using an approach that differed from that to which the patient had been initially chosen for and also if the operator was unable to cannulate the vein within 3 attempts)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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