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

Accidental Puncture of Artery During Catheter Insertion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02687126
• Other study ID #: SGNHC
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2016
• Last updated: February 23, 2016
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2016
• Source: Shahid Gangalal National Heart Centre
• Contact: Santosh S Parajuli, MD
• Phone: +9779806532132
• Email: santoshparajuli77[@]hotmail.com
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Accidental Puncture of Artery During Catheter Insertion

Intervention

Device:
• Central Venous Catheterization
Ultrasound guided internal jugular venous catheterization

Locations

Country	Name	City	State
Nepal	Shahid Gangalal NationalHeart Centre	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Gangalal National Heart Centre

Country where clinical trial is conducted

Nepal, 

References & Publications (2)

Froehlich CD, Rigby MR, Rosenberg ES, Li R, Roerig PL, Easley KA, Stockwell JA. Ultrasound-guided central venous catheter placement decreases complications and decreases placement attempts compared with the landmark technique in patients in a pediatric in — View Citation

Wigmore TJ, Smythe JF, Hacking MB, Raobaikady R, MacCallum NS. Effect of the implementation of NICE guidelines for ultrasound guidance on the complication rates associated with central venous catheter placement in patients presenting for routine surgery i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cross sectional area of internal jugular vein	Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate	up to 1 hour before intervention	No
Primary	Number of attempts for successful central venous cannulation	An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur	up to 24 hours after intervention	No
Secondary	Time to successful cannulation	Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal	up to 1 hour after intervention	No
Secondary	Number of patients with complications	Hemothorax, Pneumothorax, Local site hematoma, Arrhythmias	up to 24 hours after intervention	Yes