Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients

Not Applicable

Completed

• Conditions: Accidental Puncture of Artery During Catheter Insertion
• Interventions: Device: Central Venous Catheterization

• Registration Number: NCT02687126
• Lead Sponsor: Shahid Gangalal National Heart Centre

Brief Summary

The purpose of the study is to evaluate the success rate using ultrasound as guidance during central venous cannulation in pediatric cardiac surgical patients.

Detailed Description

Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2.5% to 22%. The landmark technique has been standard approach for many years. In comparison with landmark method, in pediatric patients, the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. This study is designed to evaluate the success rate, complications, time taken for successful cannulation and their correlation with cross sectional area of the vein.

Study Timeline

• Study First Submitted: 2016-01-15
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Results First Submitted: 2017-01-22
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Results First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1. Patients requiring central venous catheterization for elective cardiac surgery.
2. Age below 15 years.

Exclusion Criteria

1. Patient's guardian's refusal
2. Bleeding disorders
3. Clotting abnormalities (platelets count < 75,000/cumm, INR > 2)
4. Local site of infection
5. Underlying pneumothorax, pleural effusion or preoperative insertion of chest tube

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric Cardiac Surgical Patients	Central Venous Catheterization	Central Venous Catheterization

Primary Outcome Measures

Name	Time	Method
Number of Attempts for Successful Central Venous Cannulation	up to 24 hours after intervention	An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur

Secondary Outcome Measures

Name	Time	Method
Time to Successful Cannulation	up to 1 hour after intervention	Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal
Number of Patients With Complications	up to 24 hours after intervention	Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma

Trial Locations

Locations (1)

Shahid Gangalal NationalHeart Centre; 🇳🇵 Kathmandu, Bagmati, Nepal