Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization

Central Venous Catheter Placement Clinical Trial

Official title:

The Supraclavicular Fossa Ultrasound View for Correct Catheter Positioning in Infraclavicular Right Subclavian Central Venous Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812757
• Other study ID #: CVC positioning
• Status: Completed
• Start date: January 18, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2020
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.

Description:

Central venous catheterization is one of the most common procedures within intensive care medicine. Verification of correct catheter tip placement is a primary aspect of safety and quality of central venous catheterization as malposition may lead to life-threatening complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias. Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered gold standard to examine catheter tip location and evaluate for complications such as pneumo- and hemothorax. However, CXR exposes the patient to ionized radiation, requires a considerable amount of time, and is workload-generating for both ICU and radiology staff.

Weber et al has described the use of the right supraclavicular fossa view for real-time ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular vein (IJV) in adults. This approach has subsequently been validated in a clinical study and has also been used for supraclavicular subclavian line insertion. The approach requires use of a microconvex probe, which couples good image resolution and high scanning depth. The use of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion has been described previously, but this is the first description of the supraclavicular fossa ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian CVC placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for central venous catheter placement.

Exclusion Criteria:

• Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),

• Subclavian vein catheterization deemed inappropriate by the operator,

• Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)

Related Conditions & MeSH terms

• Central Venous Catheter Placement

Intervention

Diagnostic Test:
• Supraclavicular fossa US scanning
As previously stated.

Locations

Country	Name	City	State
Sweden	Skånes universitetssjukhus	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct catheter tip positioning	Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).	Post-procedural x-ray (typically within 24 hours)
Secondary	Mechanical complications within 24 hours	Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.	Within 24 hours after central venous catheterization