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

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

Study Overview

• Status: Completed
• Conditions: Central Line Complication
• Intervention / Treatment: Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • Ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.; 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.
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: Short-axis/out-of-plane approach versus oblique- axis approach for ultrasound-guided internal jugular venous catheter.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the rate of acute complications between the two groups.	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)	Post-procedure, through study completion (average 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the rate of first successful cannulation attempt.	first successful cannulation attempt (successful venous puncture and successful smooth insertion of guidewire from the first needle puncture without withdrawal of the needle)	Post procedure, through study completion (average 1 year)
the flash time.	time to completion flash time (The time interval between skin puncture and observing blood at the syringe hub)	Post procedure, through study completion (average 1 year)
the number of needle redirection.	number of needle redirection (redirection of the needle without complete withdrawal of the needle)	Post procedure, through study completion (average 1 year)
unsuccessful cannulation.	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)	Post procedure, through study completion (average 1 year)

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Engy Y Attallah, M.B.B.C.H, Anesthesia resident Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MS60/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All dana will be shared once study is completed
• IPD Sharing Time Frame: Before 1/2025
• IPD Sharing Access Criteria: Free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No