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

NCT ID: NCT05656937

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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

Keywords

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oblique orientation transverse orientation internal jugular venous cannulation ultrasound guided short axis oblique axis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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internal jugular venous cannulation

internal jugular venous cannulation

Intervention Type PROCEDURE

Eligibility Criteria

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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

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aldy Heriwardito

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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aldy heriwardito, Doctor

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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IndonesiaUAnes109

Identifier Type: -

Identifier Source: org_study_id