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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05656937
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 15.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart; Surgery, Heart, Functional Disturbance as Result; Pediatric ALL	Procedure: internal jugular venous cannulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: May 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % of patients with successful cannulation in first attempt [at the procedure of cannulation]

   The number of patients undergo cannulation with first attempt success are shown in percentage

Secondary Outcome Measures

1. % of patients with successful cannulation with designed approach [at the procedure of cannulation]

   The number of patients undergo cannulation using designed approach are shown in percentage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Central National Hospital	Jakarta		Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: aldy heriwardito, Doctor, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aldy Heriwardito, Principal Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT05656937
• Other Study ID Numbers: IndonesiaUAnes109
• First Posted: Dec 19, 2022
• Last Update Posted: Dec 19, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aldy Heriwardito, Principal Investigator, Indonesia University: oblique orientation; transverse orientation; internal jugular venous cannulation; ultrasound guided; short axis; oblique axis

Study Results

No Results Posted as of Dec 19, 2022