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

NCT06652490 | Completed DMC

• 1 other identifier: FMASU MS60/2024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Line Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference in the rate of first successful cannulation attempt.

  Post procedure, through study completion (average 1 year)

• the flash time.

  Post procedure, through study completion (average 1 year)

• the number of needle redirection.

  Post procedure, through study completion (average 1 year)

• unsuccessful cannulation.

  Post procedure, through study completion (average 1 year)

Study Arms (2)

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.

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.

Interventions

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.

Group A (control group): ( n=25 ); Group B (comparative group): ( n=25 )

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

Study Officials

• Engy Y Attallah, M.B.B.C.H

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 22, 2024
• Study Start: April 1, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2025
• Access Criteria: Free

Locations

EG (1)