Ultrasound Guided Supraclavicular and Infraclavicular Subclavian vs Catheterization in Pediatric

NCT06575491 | Completed

• 1 other identifier: 0377/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound Guided; Supraclavicular; Infraclavicular; Subclavian; Venous Catheterization; Pediatric

Outcome Measures

Primary Outcomes (1)

• Puncture time

  Puncture time was recorded.

  Interoperatively

Secondary Outcomes (4)

• Total access time

  Interoperatively

• First attempt success rate

  Interoperatively

• Quality of needle visualization

  Interoperatively

• Incidence of complication

  24 hours postoperatively

Study Arms (2)

Supraclavicular group

EXPERIMENTAL

Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization.

Device: Ultrasound-guided supraclavicular approach

Infraclavicular group

EXPERIMENTAL

Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization.

Device: Ultrasound-guided infraclavicular approach

Interventions

Ultrasound-guided supraclavicular approach DEVICE

Patients submitted to Supraclavicular approach for ultrasound-guided Subclavian veinous catheterization.

Supraclavicular group

Ultrasound-guided infraclavicular approach DEVICE

Patients submitted to Infraclavicular approach for ultrasound-guided Subclavian veinous catheterization.

Infraclavicular group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, 11796, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)