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

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

Study Overview

• Status: Completed
• Conditions: Accidental Puncture of Artery During Catheter Insertion
• Intervention / Treatment: Device: Central Venous Catheterization

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44606
      • Shahid Gangalal NationalHeart Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pediatric Cardiac Surgical Patients; Central Venous Catheterization	Device: Central Venous Catheterization; Ultrasound guided internal jugular venous catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Patients With Complications	Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma	up to 24 hours after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shahid Gangalal National Heart Centre
• Investigators: Principal Investigator: Santosh S Parajuli, MD, Shahid Gangalal National Heart Centre

Publications and helpful links

General Publications

• 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 intensive care unit. Crit Care Med. 2009 Mar;37(3):1090-6. doi: 10.1097/CCM.0b013e31819b570e.
• 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 in a tertiary referral centre. Br J Anaesth. 2007 Nov;99(5):662-5. doi: 10.1093/bja/aem262. Epub 2007 Sep 14.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SGNHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided