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

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

this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Heart; Surgery, Heart, Functional Disturbance as Result
• Intervention / Treatment: Procedure: internal jugular venous cannulation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oblique orientation; cannulation will be oblique approach	Procedure: internal jugular venous cannulation; internal jugular venous cannulation
Active Comparator: transverse approach; cannulation will be transverse approach	Procedure: internal jugular venous cannulation; internal jugular venous cannulation

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Aldy Heriwardito, Doctor, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound guided; oblique orientation; transverse orientation; internal jugular venous cannulation; short axis; oblique axis
• Other Study ID Numbers: IndonesiaUAnes109

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No