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.

Study Overview

• Status: Completed
• Conditions: Perioperative/Postoperative Complications; Vascular Access Complication
• Intervention / Treatment: Device: Long Axis strategy; Device: Short Axis Strategy

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43126
    • Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• aged <18a years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate	up to 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access Time		Hours: 0,1
Central line-associated blood stream infection		days 0-21
Number of attempts	Overall number of skin penetration and number of withdraws and redirections of the needle	hours: 0-2
Complication rate	Pneumothorax, Haemothorax, Hydrothorax, Artery puncture, Hematoma, Malpositions	Hours: 0-6-12-24

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011 Jul;39(7):1607-12. doi: 10.1097/CCM.0b013e318218a1ae.
• Matalon TA, Silver B. US guidance of interventional procedures. Radiology. 1990 Jan;174(1):43-7. doi: 10.1148/radiology.174.1.2403684.
• Abboud PA, Kendall JL. Ultrasound guidance for vascular access. Emerg Med Clin North Am. 2004 Aug;22(3):749-73. doi: 10.1016/j.emc.2004.04.003.
• Blaivas M, Brannam L, Fernandez E. Short-axis versus long-axis approaches for teaching ultrasound-guided vascular access on a new inanimate model. Acad Emerg Med. 2003 Dec;10(12):1307-11. doi: 10.1111/j.1553-2712.2003.tb00002.x.
• Blaivas M, Adhikari S. An unseen danger: frequency of posterior vessel wall penetration by needles during attempts to place internal jugular vein central catheters using ultrasound guidance. Crit Care Med. 2009 Aug;37(8):2345-9; quiz 2359. doi: 10.1097/CCM.0b013e3181a067d4.
• Shah A, Smith A, Panchatsharam S. Ultrasound-guided subclavian venous catheterisation - is this the way forward? A narrative review. Int J Clin Pract. 2013 Aug;67(8):726-32. doi: 10.1111/ijcp.12146.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (ESTIMATE): August 22, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: ultrasonography; pneumothorax; subclavian vein; central venous access; vessel view
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 16368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED