Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics

Study Overview
=================
Brief Summary
-----------------
this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients

Detailed Description
-----------------
Sixty patients randomised into two groups, 30 patients in experimental group (oblique orientation) and 30 patients in control group (transverse orientation). All cannulation took place in the operation room. Patients underwent general anesthesia and placed in supine position. Standard monitoring (electrocardiogram, non-invasive arterial pressure, pulseoxymetry) was carried out during the procedure for all patients. Before preparation of the skin, a pre-procedure ultrasound examination was performed to verify internal jugular vein patency, and its diameter was measured. Once the side had been chosen, the cannulation was performed following a sterile technique. All procedure were performed by Seldinger technique, with 22 Gauge IV catheter attached with 3 ml syringe as introducer needle. The vascular puncture was performed under ultrasound guidance, using a single-person technique. With transverse orientation, the transducer was placed transversally over the neck, and once the vein was visible in the middle of the ultrasound image, the needle was inserted in the plane perpendicular to the long axis of the transducer. With oblique orientation, the operator first obtained a transverse view of the vein and then rotated the transducer to 45 degrees (midway) between transverse and longitudinal view.

Official Title
-----------------
Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients

Conditions
-----------------
Heart; Surgery, Heart, Functional Disturbance as Result, Pediatric ALL

Intervention / Treatment
-----------------
* Procedure: internal jugular venous cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients age 3 months to 12 years old, weight 5-20 kg, male or female who undergo heart surgery and indicated to have central venous cannulation American Society of Anesthesiologist Physical Class 1-3 Family or representation of the patients agreed to participate in this study and sign informed consent Exclusion Criteria: history of surgery in the area of cannulation already placed central venous cannulation <72 hours in the same venous sign of infection, hematoma, emphysema, in the area of cannulation history of cervical trauma severe hemostatic disorder (International Normalized Ratio>2, thrombocyte <50.000, Prothrombin time>1.5 times, Activated Partial Thromboplastin Time > 1.5 times

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oblique orientation<br>cannulation will be oblique approach | Procedure: internal jugular venous cannulation<br>* internal jugular venous cannulation<br>|
| Active Comparator: transverse approach<br>cannulation will be transverse approach | Procedure: internal jugular venous cannulation<br>* internal jugular venous cannulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with successful cannulation in first attempt | The number of patients undergo cannulation with first attempt success are shown in percentage | at the procedure of cannulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with successful cannulation with designed approach | The number of patients undergo cannulation using designed approach are shown in percentage | at the procedure of cannulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oblique orientation, transverse orientation, internal jugular venous cannulation, ultrasound guided, short axis, oblique axis