Clinical trial NCT05656937: Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics
Official title: Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Pediatric ALL
Keywords: oblique orientation
transverse orientation
internal jugular venous cannulation
ultrasound guided
short axis
oblique axis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % of patients with successful cannulation in first attempt
timeFrame: at the procedure of cannulation
Secondary outcomes:
measure: % of patients with successful cannulation with designed approach
timeFrame: at the procedure of cannulation
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
Study officials:
affiliation: Indonesia University
name: aldy heriwardito, Doctor
role: PRINCIPAL_INVESTIGATOR
References: