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Completed

NCT Number: NCT01966354

Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

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.

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Key information

Conditions

Ultrasound-guided Internal Jugular Cannulation Central Venous Access Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complejo Hospitalario de Navarra, Anesthesiology department

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided Internal jugular venous approach

Procedure

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).

Primary outcomes

  1. Cannulation Success

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

    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.

Secondary outcomes

  1. Number of Cannulation Attempts

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

    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.

  2. First Attempt Cannulation

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

    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.

  3. Cannulation Time

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

    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.

  4. Mechanical Complications

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

    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.

  5. Infectious Complications

    Time frame: Once the central venous catheter is withdrawn (2 months)

    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.

Sponsors and collaborators

Lead sponsor

Mikel Batllori

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: OISO-1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 21, 2013
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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