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

NCT ID: NCT05656937

Last Updated: 2022-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oblique orientation

cannulation will be oblique approach

Group Type: EXPERIMENTAL

internal jugular venous cannulation

Intervention Type: PROCEDURE

internal jugular venous cannulation

transverse approach

cannulation will be transverse approach

Group Type: ACTIVE_COMPARATOR

internal jugular venous cannulation

Intervention Type: PROCEDURE

internal jugular venous cannulation

Interventions

internal jugular venous cannulation

internal jugular venous cannulation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Aldy Heriwardito

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

aldy heriwardito, Doctor

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto Mangunkusumo Central National Hospital

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaUAnes109

Identifier Type: -

Identifier Source: org_study_id