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

NCT01927185 | Completed

• 1 other identifier: 16368
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication; Perioperative/Postoperative Complications

Keywords

central venous access; ultrasonography; subclavian vein; pneumothorax; vessel view

Outcome Measures

Primary Outcomes (1)

• Success rate

  up to 4 hours

Secondary Outcomes (4)

• Access Time

  Hours: 0,1

• Central line-associated blood stream infection

  days 0-21

• Number of attempts

  hours: 0-2

• Complication rate

  Hours: 0-6-12-24

Study Arms (2)

Long Axis strategy

ACTIVE COMPARATOR

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

Device: Long Axis strategy

Short Axis Strategy

ACTIVE COMPARATOR

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

Device: Short Axis Strategy

Interventions

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.

Long Axis strategy

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.

Short Axis Strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• aged \<18a years

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

Parma, Parma, 43126, Italy

Location

Related Publications (6)

• 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.

  PMID: 21494105 BACKGROUND

• Matalon TA, Silver B. US guidance of interventional procedures. Radiology. 1990 Jan;174(1):43-7. doi: 10.1148/radiology.174.1.2403684.

  PMID: 2403684 BACKGROUND

• 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.

  PMID: 15301849 BACKGROUND

• 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.

  PMID: 14644780 BACKGROUND

• 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.

  PMID: 19531950 BACKGROUND

• 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.

  PMID: 23869675 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications; Pneumothorax

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Antonella Vezzani, MD

  Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

  STUDY DIRECTOR

• Tiziano Gherli, MD

  Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

  STUDY CHAIR

• Tullio Manca, MD

  Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Cardiac Surgery Intensive Care Unit

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

IT (1)