Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

N/ACompletedNCT01966354

Mikel Batllori220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

220

Conditions

Ultrasound-guided Internal Jugular Cannulation Central Venous Access Complications

Interventions

Ultrasound-guided Internal jugular venous approachPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Complejo Hospitalario de Navarra, Anesthesiology department

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

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.

Time frame: At the end of the cannulation process (180 seconds, maximum)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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