Clinical trial NCT01927185: Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation
Official title: Long-versus Short-Axis Ultrasound Guidance for Subclavian Vein Cannulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Perioperative/Postoperative Complications
Keywords: central venous access
ultrasonography
subclavian vein
pneumothorax
vessel view
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* aged \<18a years

Primary outcomes:
measure: Success rate
timeFrame: up to 4 hours
Secondary outcomes:
measure: Access Time
timeFrame: Hours: 0,1
measure: Central line-associated blood stream infection
timeFrame: days 0-21
measure: Number of attempts
timeFrame: hours: 0-2
measure: Complication rate
timeFrame: Hours: 0-6-12-24
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
Study officials:
affiliation: Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
name: Antonella Vezzani, MD
role: STUDY_DIRECTOR
affiliation: Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
name: Tiziano Gherli, MD
role: STUDY_CHAIR
affiliation: Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
name: Tullio Manca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Matalon TA, Silver B. US guidance of interventional procedures. Radiology. 1990 Jan;174(1):43-7. doi: 10.1148/radiology.174.1.2403684.
citation: 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.
citation: 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.
citation: 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.
citation: 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.