Clinical trial NCT02687126: Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients
Official title: Ultrasound Guided Technique for Internal Jugular Central Venous Catheterization in Pediatric Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Puncture of Artery During Catheter Insertion
Lead sponsor: Shahid Gangalal National Heart Centre
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Attempts for Successful Central Venous Cannulation
timeFrame: up to 24 hours after intervention
Secondary outcomes:
measure: Time to Successful Cannulation
timeFrame: up to 1 hour after intervention
measure: Number of Patients With Complications
timeFrame: up to 24 hours after intervention
Other outcomes:
measure: Cross Sectional Area of Internal Jugular Vein
timeFrame: up to 1 hour before intervention
Locations:
city: Kathmandu
country: Nepal
facility: Shahid Gangalal NationalHeart Centre
state: Bagmati
Study officials:
affiliation: Shahid Gangalal National Heart Centre
name: Santosh S Parajuli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 in a tertiary referral centre. Br J Anaesth. 2007 Nov;99(5):662-5. doi: 10.1093/bja/aem262. Epub 2007 Sep 14.