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

Sponsor
Azienda Ospedaliero-Universitaria di Parma (Other)
Overall Status
Completed
CT.gov ID
NCT01927185
Collaborator
(none)
190
1
2
33
5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Long Axis strategy
  • Device: Short Axis Strategy
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Long Axis strategy

The central venous catheterization will be performed by the long axis approach

Device: Long Axis strategy
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.

Active Comparator: Short Axis Strategy

The central venous catheterization will be performed by the short axis approach

Device: Short Axis Strategy
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.

Outcome Measures

Primary Outcome Measures

  1. Success rate [up to 4 hours]

Secondary Outcome Measures

  1. Access Time [Hours: 0,1]

  2. Central line-associated blood stream infection [days 0-21]

  3. Number of attempts [hours: 0-2]

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

  4. Complication rate [Hours: 0-6-12-24]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • aged =>18 years

  • patients who needed central venous catheter for clinical reasons

Exclusion Criteria:
  • aged <18a years

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma Parma Italy 43126

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria di Parma

Investigators

  • Study Director: Antonella Vezzani, MD, Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
  • Study Chair: Tiziano Gherli, MD, Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
  • Principal Investigator: Tullio Manca, MD, Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vezzani Antonella, Chief of the Cardiac Surgery Intensive Care Unit, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier:
NCT01927185
Other Study ID Numbers:
  • 16368
First Posted:
Aug 22, 2013
Last Update Posted:
Jan 25, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Vezzani Antonella, Chief of the Cardiac Surgery Intensive Care Unit, Azienda Ospedaliero-Universitaria di Parma
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2017