Ultrasound Guided Supraclavicular and Infraclavicular Subclavian vs Catheterization in Pediatric

Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterization in Pediatric

The aim of this study was to compare between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in pediatric to get clinical practice of rapid, accurate central venous catheter, insertion and less Complications.

Study Overview

• Status: Completed
• Conditions: Pediatric; Infraclavicular; Ultrasound Guided; Venous Catheterization; Supraclavicular; Subclavian
• Intervention / Treatment: Device: Ultrasound-guided supraclavicular approach; Device: Ultrasound-guided infraclavicular approach

Detailed Description

Vascular access in children can be challenging. There is a considerable body of evidence supporting the use of ultrasound to aid central venous access in adults, but less so in children. Benefits for experienced operators may be small, but there is evidence of benefit for those acquiring skills and for less frequent operators.

Central venous catheter (CVC) placement is one of the most important invasive procedures in the intensive care for children of all ages. And health care outcomes largely depend on the success of its implementation. There are a large number of historically and clinically significant methods of central venous catheterization, and the advantages and disadvantages of each of them have been discussed for many years.

Ultrasonography is becoming an increasingly useful adjunct in the placement of Percutaneous central lines.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged from 4 to 12 years.
• Both sexes.
• All children who need central venous line insertion.
• Intra-operative Hemodynamic monitoring.
• Volume and Inotrope Resuscitation.
• Difficult Peripheral IV Access.
• Intravenous Nutrition and Medications.

Exclusion Criteria:

• Coagulopathy.
• Distorted anatomy.
• Infection systemic or cutaneous near the proposed Point of insertion.
• Skeletal deformity.
• History of previous neck surgery.
• Head and neck mass.
• Guardian Refusal.
• Pneumothorax Or Hemothorax.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supraclavicular group; Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization.	Device: Ultrasound-guided supraclavicular approach; Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization.
Experimental: Infraclavicular group; Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization.	Device: Ultrasound-guided infraclavicular approach; Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture time	Puncture time was recorded.	Interoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total access time	Total access time was recorded	Interoperatively
First attempt success rate	First attempt success rate was recorded	Interoperatively
Quality of needle visualization	Quality of needle visualization was recorded	Interoperatively
Incidence of complication	Incidence of complication was recorded such as complication rates.failure rate haematoma, pneumothorax	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 0377/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data was available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No