Clinical trial NCT06652490: Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for US Guided IJV Catheterization in Infants.
Official title: Short-axis/out-of-plane Approach Versus Oblique- Axis Approach for Ultrasound-guided Internal Jugular Venous Catheterization in Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Line Complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be carried out on infants who require central venous access through IJV as part of their management in operating room (OR) if they consented to be part of the study from their parents.

Brief summary: 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.

Detailed description: 1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the rate of acute complications between the two groups.
timeFrame: Post-procedure, through study completion (average 1 year)
Secondary outcomes:
measure: Difference in the rate of first successful cannulation attempt.
timeFrame: Post procedure, through study completion (average 1 year)
measure: the flash time.
timeFrame: Post procedure, through study completion (average 1 year)
measure: the number of needle redirection.
timeFrame: Post procedure, through study completion (average 1 year)
measure: unsuccessful cannulation.
timeFrame: Post procedure, through study completion (average 1 year)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Anesthesia resident Ain Shams University
name: Engy Y Attallah, M.B.B.C.H
role: PRINCIPAL_INVESTIGATOR
References: