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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656937
• Other study ID #: IndonesiaUAnes109
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: December 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result
• Pediatric ALL

Intervention

Procedure:
• internal jugular venous cannulation
internal jugular venous cannulation

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	% 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