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Completed

NCT Number: NCT01927185

Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation

Central venous catheterization is commonly applied in patients undergoing cardiac surgery. The subclavian vein has lower risk of infection and provides more patients comfort. However central venous catheterization may results in complications such as pneumothorax, hemothorax or arterial puncture. It has been suggested that ultrasound (US) guidance could improve the success rate, reduce the number of needle passes and decrease complications. Two different real-time 2-dimensional US techniques can be employed in the insertion of central venous catheters. The first technique involves real-time US-guided cannulation of subclavian vein using a long axis/in-plane approach. The second one involves real-time US-guided using a short axis/out-off-plane approach. However to date no studies have compared their efficacy and safety. The purpose of this study was to compare the US-guided long-axis versus short-axis approach for the SCV catheterization in adult critical care patients.

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Key information

Conditions

Vascular Access Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Pleural Diseases Pneumothorax Postoperative Complications Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

About this study

The two techniques used for vessel visualization are far different:

The Short-Axis (SA) approach attempts to view the vessel in cross-section while venous access is obtained. The strength of the SA approach is that the vein is centered under the transducer and that the midpoint of the transducer becomes a reference point for the insertion of the needle, and that at the same time is possible to visualize SC artery and the pleural line. SA approach is easy to learn by novice sonologists.

The Long-Axis (LA) approach employs a technique that views the length of the vessel during cannulation.For this reason, with LA approach is possible to visualize the needle advance during the entire procedure from the soft tissues until the lumen of the vein, but SC artery and pleural line are not visualized in the same scan. For LA approach, practice is required to keep the needle precisely within the image and care must be taken to avoid the probe inadvertently moving away from the target structure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged =>18 years
  • patients who needed central venous catheter for clinical reasons

Exclusion criteria

  • aged <18a years

Treatment and study plan

Long Axis strategy

Device

With the long-axis approach the vein appeared in the longitudinal view. With this approach only the vein was visible on the screen. The needle was held at a 30° angle, oriented in-plane with the transducer and the skin punctured at the base of the transducer. The vessel alignment was maintained during the procedure and the entire length of the needle was visible during the progression through the tissues.

Short Axis Strategy

Device

With the short-axis approach the probe was positioned almost perpendicularly to the clavicle. The needle was held at an angle of 45° relative to the skin surface and sagittal to the plane of the probe (out-of-plane). During the progression to the vessel, the visualization of the needle was limited to the deformation of tissue and artefacts produced by needle advancement. When the tip abutted the vein wall, additional pressure produced transient vessel deformation, which disappeared once the wall was penetrated.

Primary outcomes

  1. Success rate

    Time frame: up to 4 hours

Secondary outcomes

  1. Access Time

    Time frame: Hours: 0,1

  2. Central line-associated blood stream infection

    Time frame: days 0-21

  3. Number of attempts

    Time frame: hours: 0-2

    Overall number of skin penetration and number of withdraws and redirections of the needle

  4. Complication rate

    Time frame: Hours: 0-6-12-24

    Pneumothorax, Haemothorax, Hydrothorax, Artery puncture, Hematoma, Malpositions

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2013
Registry last updated
Jan 25, 2017

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

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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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