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

Primary Purpose

Vascular Access Complication, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Long Axis strategy
Short Axis Strategy
Sponsored by
Azienda Ospedaliero-Universitaria di Parma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vascular Access Complication focused on measuring central venous access, ultrasonography, subclavian vein, pneumothorax, vessel view

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • aged <18a years

Sites / Locations

  • Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Long Axis strategy

Short Axis Strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Success rate

Secondary Outcome Measures

Access Time
Central line-associated blood stream infection
Number of attempts
Overall number of skin penetration and number of withdraws and redirections of the needle
Complication rate
Pneumothorax, Haemothorax, Hydrothorax, Artery puncture, Hematoma, Malpositions

Full Information

First Posted
August 20, 2013
Last Updated
January 24, 2017
Sponsor
Azienda Ospedaliero-Universitaria di Parma
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1. Study Identification

Unique Protocol Identification Number
NCT01927185
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria di Parma

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication, Perioperative/Postoperative Complications
Keywords
central venous access, ultrasonography, subclavian vein, pneumothorax, vessel view

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long Axis strategy
Arm Type
Active Comparator
Arm Description
The central venous catheterization will be performed by the long axis approach
Arm Title
Short Axis Strategy
Arm Type
Active Comparator
Arm Description
The central venous catheterization will be performed by the short axis approach
Intervention Type
Device
Intervention Name(s)
Long Axis strategy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Short Axis Strategy
Intervention Description
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 Outcome Measure Information:
Title
Success rate
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
Access Time
Time Frame
Hours: 0,1
Title
Central line-associated blood stream infection
Time Frame
days 0-21
Title
Number of attempts
Description
Overall number of skin penetration and number of withdraws and redirections of the needle
Time Frame
hours: 0-2
Title
Complication rate
Description
Pneumothorax, Haemothorax, Hydrothorax, Artery puncture, Hematoma, Malpositions
Time Frame
Hours: 0-6-12-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged =>18 years patients who needed central venous catheter for clinical reasons Exclusion Criteria: aged <18a years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonella Vezzani, MD
Organizational Affiliation
Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tiziano Gherli, MD
Organizational Affiliation
Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tullio Manca, MD
Organizational Affiliation
Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac Surgery. Azienda Ospedaliero Universitaria di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21494105
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.
Results Reference
background
PubMed Identifier
2403684
Citation
Matalon TA, Silver B. US guidance of interventional procedures. Radiology. 1990 Jan;174(1):43-7. doi: 10.1148/radiology.174.1.2403684.
Results Reference
background
PubMed Identifier
15301849
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.
Results Reference
background
PubMed Identifier
14644780
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.
Results Reference
background
PubMed Identifier
19531950
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.
Results Reference
background
PubMed Identifier
23869675
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.
Results Reference
background

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

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