Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.

Official Title
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Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation: Long Axis, In-plane Needle v. Short Axis, Out-of-plane Needle v. Oblique Axis, In-plane Needle

Conditions
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Ultrasound-guided Internal Jugular Cannulation, Central Venous Access Complications

Intervention / Treatment
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* Procedure: Ultrasound-guided Internal jugular venous approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 or older Indication for internal jugular venous cannulation, previously established by the doctor responsible for the patient´s hospital diagnosis and treatment Informed consent for trial participation has been obtained from the patient Exclusion Criteria: Infection signs at or close to puncture site Cutaneous erosions or subcutaneous haematoma at or close to puncture site History of internal jugular venous cannulation during the past 72 hours (in the same side in which the present cannulation is taking place) History of previous surgical interventions on the cannulation site Recent cervical trauma with present neck immobilization and without having ruled out eventual cervical spinal injury Severe coagulopathy (altered coagulation parameters and active bleeding) which cannot be promptly corrected by platelet, fresh frozen plasma or pharmacologic intervention Subcutaneous emphysema with cervical extension Agitated or uncooperative patient (including deep sedation) Inability to obtain formal informed consent from the patient or his legally authorized representative (in case the patient is legally incompetent to give informed consent) Cannulation being performed outside the surgical area or the post-anesthesia care unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long axis, in-plane needle<br>Ultrasound-guided Internal jugular venous approach Long axis, in-plane needle: Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer. | Procedure: Ultrasound-guided Internal jugular venous approach<br>* The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer. In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).<br>|
| Experimental: Short axis, out-of-plane needle<br>Ultrasound-guided Internal jugular venous approach Short axis, out-of-plane needle: Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane). | Procedure: Ultrasound-guided Internal jugular venous approach<br>* The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer. In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).<br>|
| Experimental: Oblique axis, in-plane needle<br>Ultrasound-guided Internal jugular venous approach Oblique axis, in-plane needle: Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer. | Procedure: Ultrasound-guided Internal jugular venous approach<br>* The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer. In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation Success | Cannulation will be considered as successful once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered unsuccessful. This outcome measure will be registered at the end of the cannulation process. | At the end of the cannulation process (180 seconds, maximum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cannulation Attempts | Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process. | At the end of the cannulation process (180 seconds, maximum) | 
| First Attempt Cannulation | Any cannulation that has been accomplished with a single cannulation attempt will be considered a first attempt cannulation. This outcome measure will be registered at the end of the cannulation process. | At the end of the cannulation process (180 seconds, maximum) | 
| Cannulation Time | Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process. | At the end of the cannulation process (180 seconds, maximum) | 
| Mechanical Complications | The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed. | At the end of the cannulation process (180 seconds, maximum) | 
| Infectious Complications | The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered. | Once the central venous catheter is withdrawn (2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult, catheterization, central venous, ultrasonography, interventional, evidence-based medicine, cost-benefit analysis